Trial Outcomes & Findings for Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH (NCT NCT04954742)
NCT ID: NCT04954742
Last Updated: 2026-06-17
Results Overview
echocardiographic analysis right ventricular (RV) area, measured by echocardiography.
TERMINATED
PHASE4
30 participants
Baseline to 24 weeks
2026-06-17
Participant Flow
Participants were recruited between April 2022 and May 2025. The first participant was enrolled on 13 April 2022, the last on 30 May 2025.
Overall, 30 patients were enrolled and commenced study treatment.
Participant milestones
| Measure |
Riociguat
Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study. Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks. Study medication will be provided orally with or without food. Tablets should be taken three times daily approximately 6 to 8 hours apart.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Screening
|
30
|
|
Overall Study
Baseline Visit
|
30
|
|
Overall Study
Visit 2
|
16
|
|
Overall Study
Visit 3
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Age, Continuous
|
61.23 years
STANDARD_DEVIATION 14.52 • n=30 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=30 Participants
|
|
Height
|
176.37 cm
STANDARD_DEVIATION 9.43 • n=30 Participants
|
|
Weight
|
81.97 kg
STANDARD_DEVIATION 12.49 • n=29 Participants • Values for weight are missing for one participant.
|
|
Duration of Pulmonary hypertension (PH)
|
3.59 years
STANDARD_DEVIATION 6.98 • n=30 Participants
|
|
Vital signs: Systolic blood pressure
|
120.43 mmHg
STANDARD_DEVIATION 13.94 • n=30 Participants
|
|
Vital signs: Diastolic blood pressure
|
72.03 mmHg
STANDARD_DEVIATION 12.13 • n=30 Participants
|
|
Vital signs: Heart rate
|
73.17 beats/min
STANDARD_DEVIATION 12.73 • n=30 Participants
|
|
Vital signs: Oxygen saturation (SpO2)
|
94.79 percent
STANDARD_DEVIATION 2.90 • n=29 Participants • Values for SpO2 are missing for one participant.
|
|
WHO Functional Class
I
|
0 Participants
n=30 Participants
|
|
WHO Functional Class
II
|
2 Participants
n=30 Participants
|
|
WHO Functional Class
III
|
25 Participants
n=30 Participants
|
|
WHO Functional Class
IV
|
3 Participants
n=30 Participants
|
|
PAH Etiology
Idiopathic
|
18 Participants
n=30 Participants
|
|
PAH Etiology
Heritable
|
4 Participants
n=30 Participants
|
|
PAH Etiology
Drug- and toxin-induced PAH
|
1 Participants
n=30 Participants
|
|
PAH Etiology
Connective tissue diseases
|
1 Participants
n=30 Participants
|
|
PAH Etiology
Portal hypertension
|
1 Participants
n=30 Participants
|
|
PAH Etiology
PAH with comorbiditis
|
5 Participants
n=30 Participants
|
|
Concomitant diseases
Asthma
|
3 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Obstructive sleep apnea syndrome
|
3 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Mild COPD
|
11 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Mild restrictive lung disease
|
4 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Bronchiectasis
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Hypoxemia
|
13 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Pulmonary embolism
|
4 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Treated arterial hypertension
|
16 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Heart block
|
4 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Arrythmias
|
4 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Treated coronary heart disease
|
14 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
HFpEF
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Varicosis
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Peripheral arterial occlusive disease
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Vitamin D deficiency
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Hyperuricemia
|
4 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Adipositas
|
5 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Diabetes mellitus
|
7 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Dyslipidemia
|
8 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Thyroid dysfunction
|
5 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Iron deficiency
|
7 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Past infections (any)
|
8 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Prostate hyperplasia
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Seminoma
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Steirlisation
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Ureterolithiasis
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Sinusitis
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Sinus osteoma
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Hypacusis
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Nasal hyperplasia
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Tonsillectomy
|
3 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Portal hypertension
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Gastritis
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
State after Appendectomy
|
4 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
State after Cholezystectomy
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Diverticulosis
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Hepatic coagulation disorder
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Liver fibrom
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Depression
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Total endoprothesis
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Echocardiography at rest: Qualitative assesment of left ventricular pump function
mild impairment
|
1 Participants
n=30 Participants
|
|
Concomitant diseases
Gout
|
2 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Concomitant diseases
Scoliosis
|
1 Participants
n=30 Participants • Some participants had more than one concomitant disease, therefore the numbers in the row differ from the overall participant number.
|
|
Blood gas analysis: Oxygen saturation (SaO2)
|
94.14 percent
STANDARD_DEVIATION 2.56 • n=26 Participants • Values for blood gas analysis are missing for four participants.
|
|
Blood gas analysis: Partial pressure of oxygen (PaO2)
|
69.00 mmHg
STANDARD_DEVIATION 10.71 • n=29 Participants • Values for blood gas analysis are missing for one participant.
|
|
Blood gas analysis: Partial pressure of carbon dioxide (PaCO2)
|
33.99 mmHg
STANDARD_DEVIATION 4.75 • n=29 Participants • Values for blood gas analysis are missing for one participant.
|
|
Blood gas analysis: pH
|
7.43 pH
STANDARD_DEVIATION 0.04 • n=29 Participants • Values for blood gas analysis are missing for one participant.
|
|
Blood gas analysis: Bicarbonates
|
22.54 mmol/l
STANDARD_DEVIATION 3.09 • n=28 Participants • Values for bicarbonates are missing for two participants.
|
|
Blood gas analysis: Base excess
|
-1.14 mmol/l
STANDARD_DEVIATION 2.77 • n=28 Participants • Values for base excess are missing for two participants.
|
|
Hemodynamics at rest: Right atrial pressure (RAP)
|
6.13 mmHg
STANDARD_DEVIATION 3.33 • n=30 Participants
|
|
Hemodynamics at rest: systolic pulmonary arterial pressure (sPAP)
|
68.10 mmHg
STANDARD_DEVIATION 19.73 • n=30 Participants
|
|
Hemodynamics at rest: diastolic pulmonary arterial pressure (dPAP)
|
25.53 mmHg
STANDARD_DEVIATION 6.02 • n=30 Participants
|
|
Hemodynamics at rest: mean pulmonary arterial pressure (mPAP)
|
40.97 mmHg
STANDARD_DEVIATION 9.44 • n=30 Participants
|
|
Hemodynamics at rest: Pulmonary arterial wedge pressure (PAWP)
|
9.07 mmHg
STANDARD_DEVIATION 3.06 • n=30 Participants
|
|
Hemodynamics at rest: Cardiac output (CO)
|
5.25 l/min
STANDARD_DEVIATION 1.56 • n=30 Participants
|
|
Hemodynamics at rest: Cardiac index (CI)
|
2.62 l/min/m^2
STANDARD_DEVIATION 0.74 • n=30 Participants
|
|
Hemodynamics at rest: Pulmonary vascular resistance (PVR)
|
6.72 WU
STANDARD_DEVIATION 3.47 • n=30 Participants
|
|
Hemodynamics at rest: Venous oxygen saturation (SvO2)
|
70.47 percent
STANDARD_DEVIATION 6.98 • n=30 Participants
|
|
6 Minute walking distance: Distance
|
359.83 m
STANDARD_DEVIATION 123.01 • n=30 Participants
|
|
6 Minute walking distance: Oxygen saturation at test end
|
87.17 percent
STANDARD_DEVIATION 8.69 • n=30 Participants
|
|
6 Minute walking distance: Borg dyspnea score
|
4.00 scores on a scale
STANDARD_DEVIATION 3.05 • n=30 Participants
|
|
Short Form-36 Heath Survey: Physical functioning
|
54.14 scores on a scale
STANDARD_DEVIATION 26.99 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Physical role functioning
|
49.14 scores on a scale
STANDARD_DEVIATION 45.55 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Pain
|
85.83 scores on a scale
STANDARD_DEVIATION 19.79 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Echocardiography at rest: Left atrial (LA) diameter
|
3.27 cm
STANDARD_DEVIATION 0.53 • n=29 Participants • Value for LA diameter is missing for one participant.
|
|
Echocardiography at rest: Diameter of pulmonary artery (PA)
|
2.96 cm
STANDARD_DEVIATION 0.75 • n=24 Participants • Values for Diameter of pulmonary artery are missing for six participants.
|
|
Echocardiography at rest: Qualitative assesment of left ventricular pump function
normal/good
|
29 Participants
n=30 Participants
|
|
Short Form-36 Heath Survey: General health perception
|
50.76 scores on a scale
STANDARD_DEVIATION 19.74 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Vitality
|
51.90 scores on a scale
STANDARD_DEVIATION 18.15 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Social functioning
|
76.90 scores on a scale
STANDARD_DEVIATION 23.31 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Emotional role function
|
75.86 scores on a scale
STANDARD_DEVIATION 37.72 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Mental well-being
|
70.76 scores on a scale
STANDARD_DEVIATION 19.22 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Physical summation score
|
58.17 scores on a scale
STANDARD_DEVIATION 19.65 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Short Form-36 Heath Survey: Mental summation score
|
65.14 scores on a scale
STANDARD_DEVIATION 18.19 • n=29 Participants • Values for Short Form-36 survey are missing for one participant.
|
|
Echocardiography at rest: estimated systolic pulmonary arterial pressure (sPAP)
|
57.83 mmHg
STANDARD_DEVIATION 17.04 • n=30 Participants
|
|
Echocardiography at rest: Right atrial (RA) area
|
22.50 cm^2
STANDARD_DEVIATION 6.14 • n=30 Participants
|
|
Echocardiography at rest: Right ventricular (RV) area
|
26.10 cm^2
STANDARD_DEVIATION 5.50 • n=30 Participants
|
|
Echocardiography at rest: Tricuspid annular plane systolic excursion (TAPSE)
|
2.15 cm
STANDARD_DEVIATION 0.42 • n=30 Participants
|
|
Echocardiography at rest: Left ventricular eccentricity index (LV-EI)
|
1.32 index
STANDARD_DEVIATION 0.24 • n=29 Participants • Value for LV-EI is missing for one participant.
|
|
Echocardiography at rest: Fractional area change (FAC)
|
16.96 percent
STANDARD_DEVIATION 5.18 • n=23 Participants • Values for FAC are missing for seven participants.
|
|
Echocardiography at rest: Inferior vena cava (IVC) diameter
|
1.64 cm
STANDARD_DEVIATION 0.46 • n=30 Participants
|
|
Echocardiography at rest: Inferior vena cava (IVC) collapse
|
53.19 %
STANDARD_DEVIATION 23.08 • n=27 Participants • Values for IVC collapse are missing for 3 participants.
|
|
Echocardiography at rest: Qualitative assesment of left ventricular pump function
moderate impairment
|
0 Participants
n=30 Participants
|
|
Echocardiography at rest: Qualitative assesment of left ventricular pump function
severe impairment
|
0 Participants
n=30 Participants
|
|
Echocardiography at rest: Qualitative assesment of right ventricular pump function
normal/good
|
1 Participants
n=30 Participants
|
|
Echocardiography at rest: Qualitative assesment of right ventricular pump function
mild impairment
|
3 Participants
n=30 Participants
|
|
Echocardiography at rest: Qualitative assesment of right ventricular pump function
moderate impairment
|
6 Participants
n=30 Participants
|
|
Echocardiography at rest: Qualitative assesment of right ventricular pump function
severe impairment
|
20 Participants
n=30 Participants
|
|
Echocardiography at rest: Left ventricular diastolic dysfunction
No
|
15 Participants
n=30 Participants
|
|
Echocardiography at rest: Left ventricular diastolic dysfunction
Yes
|
15 Participants
n=30 Participants
|
|
Lung function: Forced vital capacity (FVC)
|
84.54 %predicted
STANDARD_DEVIATION 11.37 • n=30 Participants
|
|
Lung function: Forced expiratory volume in 1 second (FEV1)
|
81.95 %predicted
STANDARD_DEVIATION 11.85 • n=30 Participants
|
|
Lung function: Total lung capacity (TLC)
|
91.04 %(predicted)
STANDARD_DEVIATION 12.54 • n=30 Participants
|
|
Lung function: Residual volume (RV)
|
99.29 %predicted
STANDARD_DEVIATION 26.40 • n=30 Participants
|
|
Lung function: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
|
51.64 %predicted
STANDARD_DEVIATION 21.53 • n=29 Participants • Value for DLCO is missing for one participant.
|
|
Lung function: Diffusion Capacity corrected for Alveolar Volume (DLCO/VA)
|
59.92 %predicted
STANDARD_DEVIATION 23.33 • n=29 Participants • Value for DLCO/VA is missing for one participant.
|
|
Laboratory: Hemoglobin
|
15.48 g/dl
STANDARD_DEVIATION 2.23 • n=28 Participants • Values for Hemoglobin are missing for two participants.
|
|
Laboratory: Hematocrit
|
0.46 (MEAN)
STANDARD_DEVIATION 0.06 • n=28 Participants • Values for Hematocrit are missing for two participants.
|
|
Laboratory: Creatinine
|
1.05 mg/dl
STANDARD_DEVIATION 0.24 • n=28 Participants • Values for Creatine are missing for two participants.
|
|
Laboratory: Urea
|
38.14 mg/dl
STANDARD_DEVIATION 18.40 • n=28 Participants • Values for Urea are missing for two participants.
|
|
Laboratory: Uric acid
|
6.71 mg/dl
STANDARD_DEVIATION 2.17 • n=28 Participants • Values for Uric acid are missing for two participants.
|
|
Laboratory: SGOT
|
27.43 U/l
STANDARD_DEVIATION 22.46 • n=28 Participants • Values for SGOT are missing for two participants.
|
|
Laboratory: SGPT
|
29.50 U/l
STANDARD_DEVIATION 33.63 • n=28 Participants • Values for SGPT are missing for two participants.
|
|
Laboratory: CRP
|
5.00 mg/l
STANDARD_DEVIATION 7.03 • n=27 Participants • Values for CRP are missing for three participants.
|
|
Laboratory: Sodium
|
140.39 mmol/l
STANDARD_DEVIATION 1.83 • n=28 Participants • Values for Sodium are missing for two participants.
|
|
Laboratory: NTproBNP
|
1555.04 ng/l
STANDARD_DEVIATION 3165.73 • n=28 Participants • Values for NTproBNP are missing for two participants.
|
|
CPET: Systolic blood pressure
Systolic blood pressure at rest
|
115.33 mmHg
STANDARD_DEVIATION 9.62 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
|
|
CPET: Systolic blood pressure
Systolic blood pressure at anaerobic threshold
|
145.73 mmHg
STANDARD_DEVIATION 16.64 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
|
|
CPET: Systolic blood pressure
Systolic blood pressure at peak workload
|
151.83 mmHg
STANDARD_DEVIATION 16.79 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
|
|
CPET: Diastolic blood pressure
Diastolic blood pressure at rest
|
72.42 mmHg
STANDARD_DEVIATION 6.02 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Diastolic blood pressure
Diastolic blood pressure at anaerobic threshold
|
86.91 mmHg
STANDARD_DEVIATION 8.98 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Diastolic blood pressure
Diastolic blood pressure at peak workload
|
84.67 mmHg
STANDARD_DEVIATION 12.95 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Heart rate
Heart rate at rest
|
74.75 beats/min
STANDARD_DEVIATION 9.17 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Heart rate
Heart rate at anaerobic threshold
|
104.82 beats/min
STANDARD_DEVIATION 17.30 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Heart rate
Heart rate at peak workload
|
124.17 beats/min
STANDARD_DEVIATION 18.86 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Volume of oxygen consumption (VO2) in total
VO2 at rest
|
362.33 ml/min
STANDARD_DEVIATION 125.05 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Volume of oxygen consumption (VO2) in total
VO2 at anaerobic threshold
|
909.45 ml/min
STANDARD_DEVIATION 390.23 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Volume of oxygen consumption (VO2) in total
VO2 at peak workload
|
1180.75 ml/min
STANDARD_DEVIATION 427.69 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Volume of Oxygen consumption per kg of bodyweight (VO2/kg)
VO2/kg at rest
|
4.38 ml/min/kg
STANDARD_DEVIATION 1.03 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
|
|
CPET: Volume of Oxygen consumption per kg of bodyweight (VO2/kg)
VO2/kg at anaerobic threshold
|
10.66 ml/min/kg
STANDARD_DEVIATION 4.14 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
|
|
CPET: Volume of Oxygen consumption per kg of bodyweight (VO2/kg)
VO2/kg at peak workload
|
14.24 ml/min/kg
STANDARD_DEVIATION 4.22 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
|
|
CPET: Volume of exhaled carbondioxide (VCO2)
VCO2 at rest
|
329.17 ml/min
STANDARD_DEVIATION 125.58 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Volume of exhaled carbondioxide (VCO2)
VCO2 at anaerobic threshold
|
886.82 ml/min
STANDARD_DEVIATION 483.67 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Volume of exhaled carbondioxide (VCO2)
VCO2 at peak workload
|
1353.58 ml/min
STANDARD_DEVIATION 519.86 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Oxygen saturation (SpO2)
SpO2 at rest
|
97.00 percent
STANDARD_DEVIATION 2.00 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Oxygen saturation (SpO2)
SpO2 at anaerobic threshold
|
92.00 percent
STANDARD_DEVIATION 6.97 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Oxygen saturation (SpO2)
SpO2 at peak workload
|
90.67 percent
STANDARD_DEVIATION 8.12 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Minute Ventilation (VE)
VE at rest
|
15.33 L/min
STANDARD_DEVIATION 6.39 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Minute Ventilation (VE)
VE at anaerobic threshold
|
38.36 L/min
STANDARD_DEVIATION 15.28 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Minute Ventilation (VE)
VE at peak workload
|
57.75 L/min
STANDARD_DEVIATION 15.97 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: O2-pulse
O2-pulse at rest
|
4.91 ml
STANDARD_DEVIATION 1.77 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: O2-pulse
O2-pulse at anaerobic threshold
|
8.71 ml
STANDARD_DEVIATION 3.19 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: O2-pulse
O2-pulse at peak workload
|
9.52 ml
STANDARD_DEVIATION 3.19 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Equivalents for O2 at rest
|
40.50 ratio
STANDARD_DEVIATION 0.71 • n=2 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Respiratory reserve
Respiratory reserve at rest
|
52.75 percent
STANDARD_DEVIATION 44.18 • n=8 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Respiratory reserve
Respiratory reserve at anaerobic threshold
|
41.50 percent
STANDARD_DEVIATION 21.76 • n=8 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: Respiratory reserve
Respiratory reserve at peak workload
|
40.55 percent
STANDARD_DEVIATION 13.19 • n=9 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: workload
Workload at anaerobic threshold
|
65.91 watt
STANDARD_DEVIATION 34.05 • n=11 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
CPET: workload
Peak workload
|
95.83 watt
STANDARD_DEVIATION 45.02 • n=12 Participants • CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduzed number of participants.
|
|
Laboratory: Bilirubin
|
0.82 mg/dl
STANDARD_DEVIATION 0.51 • n=28 Participants • Values for Bilirubin are missing for two participants.
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis right ventricular (RV) area, measured by echocardiography.
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in RV (Right Ventricular) Area
|
-6.00 cm^2
Standard Deviation 3.80
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in RA (Right Atrial) Area
|
-3.17 cm^2
Standard Deviation 5.91
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in RV (Right Ventricular) Area
|
-6.50 cm^2
Interval -9.01 to -3.99
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in RA (Right Atrial) Area
|
-3.13 cm^2
Interval -5.64 to -0.61
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Systolic Pulmonary Artery Pressure (sPAP)
|
-7.75 mmHg
Interval -15.02 to -0.48
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Systolic Pulmonary Artery Pressure (sPAP)
|
-4.33 mmHg
Interval -10.05 to 1.39
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=22 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in RV Fractional Area Change (FAC)
|
6.32 % of end-diastolic area
Standard Deviation 8.99
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: Population description: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=11 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in RV Fractional Area Change (FAC)
|
3.18 % of end-diastolic area
Interval 0.2 to 6.17
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=11 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Peak Velocity of Tricuspid Regurgitation (TRV)
|
0.04 m/s
Interval -0.58 to 0.65
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=21 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Peak Velocity of Tricuspid Regurgitation (TRV)
|
-0.21 m/s
Interval -0.55 to 0.13
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Inferior Vena Cava (IVC) Diameter
|
-0.05 cm
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Inferior Vena Cava (IVC) Diameter
|
-0.22 cm
Interval -0.54 to 0.1
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: RVOT VTI was a pre-specified echocardiographic parameter; however, it was not collected or analyzed in this study due to inherent technical limitations of the echocardiography system used at the study site. As a result, no RVOT VTI data were available for analysis.
echocardiographic analysis
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in left ventricular eccentricity index (LV-EI) from baseline at 24 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perpendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Eccentricity Index (EI)
|
-0.12 index
Interval -0.24 to 0.0
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in left ventricular eccentricity index (LV-EI) from baseline at 12 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perpendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Eccentricity Index (EI)
|
-0.25 index
Interval -0.41 to -0.09
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
|
0.16 cm
Interval -0.09 to 0.4
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Tricuspid Annular Plane Systolic Excursion (TAPSE)
|
0.16 cm
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function improvement (+2)
|
2 Participants
|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function improvement (+1)
|
6 Participants
|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function unchanged
|
21 Participants
|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function deterioration (-1)
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Left Ventricular Pump Function (Qualitative)
LV-function unchanged
|
30 Participants
|
|
Change in Left Ventricular Pump Function (Qualitative)
LV-function changed
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function improvement (+1)
|
2 Participants
|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function unchanged
|
13 Participants
|
|
Change in Right Ventricular Pump Function (Qualitative)
RV-function deterioration (-1)
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Left Ventricular Pump Function (Qualitative)
Improvement
|
0 Participants
|
|
Change in Left Ventricular Pump Function (Qualitative)
Unchanged
|
16 Participants
|
|
Change in Left Ventricular Pump Function (Qualitative)
Deterioration
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Left Atrial (LA) Diameter
|
0.18 cm
Interval -0.22 to 0.57
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Left Atrial (LA) Diameter
|
0.11 cm
Interval -0.11 to 0.33
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time)
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Left Ventricular (LV) Diastolic Function
Improvement
|
3 Participants
|
|
Change in Left Ventricular (LV) Diastolic Function
Unchanged
|
12 Participants
|
|
Change in Left Ventricular (LV) Diastolic Function
Worsening
|
1 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic Analysis measured as: (LV transmitral E wave and A wave, E' wave of interventricular septum and lateral wall pulsed tissue Doppler, isovolumic relaxation time, mitral deceleration time)
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Left Ventricular (LV) Diastolic Function
Improvement
|
5 Participants
|
|
Change in Left Ventricular (LV) Diastolic Function
Unchanged
|
23 Participants
|
|
Change in Left Ventricular (LV) Diastolic Function
Worsening
|
2 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic Analysis
Outcome measures
| Measure |
Riociguat Group
n=12 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Diameters of Pulmonary Artery (PA)
|
-0.17 cm
Interval -0.41 to 0.08
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic Analysis
Outcome measures
| Measure |
Riociguat Group
n=24 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Diameters of Pulmonary Artery (PA)
|
-0.21 cm
Interval -0.54 to 0.12
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Cardiac Index (CI)
|
0.24 l/min/m^2
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Cardiac Output (CO)
|
0.41 l/min
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Systolic Pulmonary Arterial Pressure (sPAP)
|
3.29 mmHg
Interval -4.37 to 10.96
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Diastolic Pulmonary Arterial Pressure (dPAP)
|
-0.12 mmHg
Interval -3.1 to 2.86
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Mean Pulmonary Arterial Pressure (mPAP)
|
0.65 mmHg
Interval -3.0 to 4.3
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Pulmonary Arterial Wedge Pressure (PAWP)
|
1.76 mmHg
Interval -1.14 to 4.67
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Right Atrial Pressure (RAP)
|
0.24 mmHg
Interval -1.99 to 2.46
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Pulmonary Vascular Resistance (PVR)
|
-1.04 WU
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: baseline and after 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Pulmonary hemodynamics by right heart catheterization
Outcome measures
| Measure |
Riociguat Group
n=17 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Central Venous Saturation From Pulmonary Artery
|
0.53 Percent
Interval -1.81 to 2.87
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in exercise capacity
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in 6-minute Walking Distance
|
26.13 m
Interval -2.22 to 54.47
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in exercise capacity
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in 6-minute Walking Distance
|
41.00 m
Standard Deviation 57.94
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Forced Vital Capacity (FVC)
|
0.87 %predicted
Interval -3.49 to 5.22
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Forced Vital Capacity (FVC)
|
0.91 %predicted
Interval -4.65 to 6.47
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1)
|
-2.76 %predicted
Interval -7.09 to 1.57
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1)
|
-1.26 %predicted
Interval -5.82 to 3.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in FEV1% of Maximal Vital Capacity (VC Max)
|
-3.51 % predicted
Interval -6.69 to -0.33
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in FEV1% of Maximal Vital Capacity (VC Max)
|
-1.34 % predicted
Interval -3.5 to 0.81
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Total Lung Capacity (TLC)
|
-0.46 %(predicted)
Interval -5.23 to 4.31
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Total Lung Capacity (TLC)
|
2.12 %(predicted)
Interval -4.06 to 8.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Residual Volume (RV)
|
-2.68 %predicted
Interval -10.35 to 5.0
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Residual Volume (RV)
|
1.34 %predicted
Interval -7.5 to 10.18
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Diffusion-limited Carbon Monoxide (DLCO)
|
0.22 %predicted
Interval -2.54 to 2.99
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Diffusion-limited Carbon Monoxide (DLCO)
|
-1.38 %predicted
Interval -3.88 to 1.12
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in DLCO/VA (Krogh) Factor
|
1.02 %predicted
Interval -1.75 to 3.79
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in Lung function Tests
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in DLCO/VA (Krogh) Factor
|
1.19 %predicted
Interval -1.33 to 3.71
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Partial Pressure of Oxygen (pO2)
|
-1.80 mmHg
Interval -7.47 to 3.87
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=29 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Partial Pressure of Oxygen (pO2)
|
-3.28 mmHg
Interval -6.87 to 0.32
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Partial Pressure of Carbon Dioxide (pCO2)
|
-0.04 mmHg
Interval -1.71 to 1.62
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=29 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Partial Pressure of Carbon Dioxide (pCO2)
|
-0.90 mmHg
Interval -2.31 to 0.5
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Saturation (SaO2)
|
-0.46 percent
Interval -1.79 to 0.87
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=24 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Saturation (SaO2)
|
-2.31 percent
Interval -4.32 to -0.3
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=29 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in pH
|
0.01 pH
Interval 0.0 to 0.02
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in capillary or arterial blood gas analysis
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in pH
|
0.00 pH
Interval -0.01 to 0.01
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally, visit 2 was skipped for several patients which further reduced the number of evaluable patients. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Blood Pressure
Systolic blood pressure at rest
|
-5.50 mmHg
Standard Deviation 13.44
|
|
Change in Blood Pressure
Systolic blood pressure at anaerobic threshold
|
-7.50 mmHg
Standard Deviation 20.51
|
|
Change in Blood Pressure
Systolic blood pressure at peak workload
|
25.00 mmHg
Standard Deviation 41.01
|
|
Change in Blood Pressure
Diastolic blood pressure at rest
|
0.50 mmHg
Standard Deviation 7.78
|
|
Change in Blood Pressure
Diastolic blood pressure at anaerobic threshold
|
-16.50 mmHg
Standard Deviation 12.02
|
|
Change in Blood Pressure
Diastolic blood pressure at peak workload
|
-16.00 mmHg
Standard Deviation 5.66
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Blood Pressure
Systolic blood pressure at rest
|
3.90 mmHg
Interval -1.9 to 9.7
|
|
Change in Blood Pressure
Systolic blood pressure at anareobic threshold
|
10.22 mmHg
Interval -8.53 to 28.98
|
|
Change in Blood Pressure
Systolic blood pressure at peak workload
|
12.70 mmHg
Interval -0.69 to 26.09
|
|
Change in Blood Pressure
Diastolic blood pressure at rest
|
3.60 mmHg
Interval -1.69 to 8.89
|
|
Change in Blood Pressure
Diastolic blood pressure at anaerobic threshold
|
-0.67 mmHg
Interval -10.03 to 8.7
|
|
Change in Blood Pressure
Diastolic blood pressure at peak workload
|
4.00 mmHg
Interval -7.41 to 15.41
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which further reduced the number of participants that performed CPET after 12 weeks . Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Heart Rate
Heart rate at rest
|
7.00 beats/min
Standard Deviation 11.31
|
|
Change in Heart Rate
Heart rate at anaerobic threshold
|
1.50 beats/min
Standard Deviation 16.26
|
|
Change in Heart Rate
Heart rate at peak workload
|
19.50 beats/min
Standard Deviation 3.54
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Heart Rate
Heart rate at rest
|
-3.20 beats/min
Interval -7.97 to 1.57
|
|
Change in Heart Rate
Heart rate at anaerobic threshold
|
8.22 beats/min
Interval -4.9 to 21.34
|
|
Change in Heart Rate
Heart rate at peak workload
|
9.70 beats/min
Interval 2.1 to 17.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Workload
Workload at anaerobic threshold
|
12.50 watt
Standard Deviation 53.03
|
|
Change in Workload
Peak workload
|
12.50 watt
Standard Deviation 17.68
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Workload
Workload at anaerobic threshold
|
30.56 watts
Interval 7.46 to 53.65
|
|
Change in Workload
Peak workload
|
20.00 watts
Interval 8.69 to 31.31
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Consumption as Total (VO2)
VO2 at rest
|
-78.00 ml/min
Interval -149.1 to -6.9
|
|
Change in Oxygen Consumption as Total (VO2)
VO2 at anaerobic threshold
|
293.78 ml/min
Interval 26.24 to 561.31
|
|
Change in Oxygen Consumption as Total (VO2)
VO2 at peak workload
|
171.22 ml/min
Interval 49.13 to 293.31
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Consumption as Total (VO2)
VO2 at rest
|
-56.50 ml/min
Standard Deviation 135.057
|
|
Change in Oxygen Consumption as Total (VO2)
VO2 at anaerobic threshold
|
-114.50 ml/min
Standard Deviation 655.49
|
|
Change in Oxygen Consumption as Total (VO2)
VO2 at peak workload
|
319.00 ml/min
Standard Deviation 135.76
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally, visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants..
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Exhaled Carbon Dioxide (VCO2)
VCO2 at rest
|
-38.00 ml/min
Standard Deviation 192.33
|
|
Change in Exhaled Carbon Dioxide (VCO2)
VCO2 at anaerobic threshold
|
-131.00 ml/min
Standard Deviation 823.07
|
|
Change in Exhaled Carbon Dioxide (VCO2)
VCO2 at peak workload
|
449.50 ml/min
Standard Deviation 103.94
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=9 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Exhaled Carbon Dioxide (VCO2)
VCO2 at rest
|
-97.22 ml/min
Interval -181.23 to -13.22
|
|
Change in Exhaled Carbon Dioxide (VCO2)
VCO2 at anaerobic threshold
|
445.50 ml/min
Interval 40.68 to 850.32
|
|
Change in Exhaled Carbon Dioxide (VCO2)
VCO2 at peak workload
|
204.13 ml/min
Interval 40.38 to 367.87
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Saturation (SpO2)
SpO2 at rest
|
1.00 percent
Standard Deviation 0.00
|
|
Change in Oxygen Saturation (SpO2)
SpO2 at anaerobic threshold
|
-2.00 percent
Standard Deviation 2.83
|
|
Change in Oxygen Saturation (SpO2)
SpO2 at peak workload
|
-0.50 percent
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Saturation (SpO2)
SpO2 at rest
|
0.60 percent
Interval -0.84 to 2.04
|
|
Change in Oxygen Saturation (SpO2)
SpO2 at anaerobic threshold
|
1.33 percent
Interval -2.31 to 4.98
|
|
Change in Oxygen Saturation (SpO2)
SpO2 at peak workload
|
0.78 percent
Interval -2.52 to 4.08
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Pulse
O2-pulse at rest
|
-1.06 ml/beat
Standard Deviation 0.98
|
|
Change in Oxygen Pulse
O2-pulse at anaerobic threshold
|
-0.95 ml/beat
Standard Deviation 3.81
|
|
Change in Oxygen Pulse
O2-pulse at peak workload
|
0.36 ml/beat
Standard Deviation 1.44
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Pulse
O2-pulse at rest
|
-0.77 ml/beat
Interval -1.52 to -0.02
|
|
Change in Oxygen Pulse
O2-pulse at anaerobic threshold
|
1.98 ml/beat
Interval -0.05 to 4.0
|
|
Change in Oxygen Pulse
O2-pulse at peak workload
|
0.45 ml/beat
Interval -0.73 to 1.62
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Minute Ventilation (VE)
Minute ventilation at rest
|
-1.00 L/min
Standard Deviation 5.66
|
|
Change in Minute Ventilation (VE)
Minute ventilation at anaerobic threshold
|
-5.50 L/min
Standard Deviation 24.75
|
|
Change in Minute Ventilation (VE)
Minute ventilation at peak workload
|
17.50 L/min
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Minute Ventilation (VE)
Minute ventilation at rest
|
1.80 L/min
Interval -13.48 to 17.08
|
|
Change in Minute Ventilation (VE)
Minute ventilation at anaerobic threshold
|
14.67 L/min
Interval 2.81 to 26.52
|
|
Change in Minute Ventilation (VE)
Minute ventilation at peak workload
|
16.00 L/min
Interval 10.06 to 21.94
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally visit 2 was skipped for several patients which reduced the number of participants that performed CPET after 12 weeks further. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing: The respiratory equivalent for oxygen represents the ratio of minute ventilation (VE) to oxygen uptake (VO₂) and reflects the efficiency of ventilation relative to oxygen consumption.
Outcome measures
| Measure |
Riociguat Group
n=1 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Respiratory Equivalents for Oxygen at Rest
|
-1.20 ratio
Standard Deviation NA
SD is not reported when n=1 because variability cannot be assessed from a single observation. Since there is no dispersion and the calculation would involve division by zero (n-1=0), the standard deviation is undefined.
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing: The respiratory equivalent for oxygen represents the ratio of minute ventilation (VE) to oxygen uptake (VO₂) and reflects the efficiency of ventilation relative to oxygen consumption.
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Respiratory Equivalents for Oxygen at Rest
|
-10.45 ratio
Interval -88.59 to 67.69
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: This measurement was not implemented during the study period, and therefore no data were collected. Consequently, no analysis is possible and none is planned.
Change in Cardiopulmonary exercise testing: The respiratory equivalent for carbon dioxide represents the ratio of minute ventilation (VE) to carbon dioxide production (VCO₂) and reflects ventilatory efficiency with respect to carbon dioxide elimination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: This measurement was not implemented during the study period, and therefore no data were collected. Consequently, no analysis is possible and none is planned.
Change in Cardiopulmonary exercise testing: The respiratory equivalent for carbon dioxide represents the ratio of minute ventilation (VE) to carbon dioxide production (VCO₂) and reflects ventilatory efficiency with respect to carbon dioxide elimination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=1 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Respiratory Reserve
Respiratory reserve at rest
|
-81.00 percent respiratory reserve
Standard Deviation NA
SD is not reported when n=1 because variability cannot be assessed from a single observation. Since there is no dispersion and the calculation would involve division by zero (n-1=0), the standard deviation is undefined.
|
|
Change in Respiratory Reserve
Respiratory reserve at anaerobic threshold
|
-24.00 percent respiratory reserve
Standard Deviation NA
SD is not reported when n=1 because variability cannot be assessed from a single observation. Since there is no dispersion and the calculation would involve division by zero (n-1=0), the standard deviation is undefined.
|
|
Change in Respiratory Reserve
Respiratory reserve at peak workload
|
-18.00 percent respiratory reserve
Standard Deviation NA
SD is not reported when n=1 because variability cannot be assessed from a single observation. Since there is no dispersion and the calculation would involve division by zero (n-1=0), the standard deviation is undefined.
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Respiratory Reserve
Respiratory reserve at rest
|
-72.60 percent respiratory reserve
Standard Deviation NA
SD is not reported when n=1 because variability cannot be assessed from a single observation. Since there is no dispersion and the calculation would involve division by zero (n-1=0), the standard deviation is undefined.
|
|
Change in Respiratory Reserve
Respiratory reserve at anaerobic threshold
|
-19.20 percent respiratory reserve
Standard Deviation NA
SD is not reported when n=1 because variability cannot be assessed from a single observation. Since there is no dispersion and the calculation would involve division by zero (n-1=0), the standard deviation is undefined.
|
|
Change in Respiratory Reserve
Respiratory reserve at peak workload
|
-11.25 percent respiratory reserve
Standard Deviation 12.66
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in WHO functional class
Outcome measures
| Measure |
Riociguat Group
n=16 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
WHO FC
Improvement (-1)
|
6 Participants
|
|
WHO FC
Unchanged
|
10 Participants
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in WHO functional class
Outcome measures
| Measure |
Riociguat Group
n=30 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
WHO FC
Improvement (-2)
|
2 Participants
|
|
WHO FC
Improvement (-1)
|
15 Participants
|
|
WHO FC
Worsening (+1)
|
1 Participants
|
|
WHO FC
Unchanged
|
12 Participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
NT-proBNP
|
71.86 ng/l
Interval -260.32 to 404.03
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
NT-proBNP
|
-21.04 ng/l
Standard Deviation 2144.27
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Haemoglobin Changes
|
-0.49 g/dl
Interval -1.07 to 0.09
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=27 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Haemoglobin Changes
|
-0.54 g/dl
Interval -1.01 to -0.07
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Haematocrit Changes
|
-0.02 Ratio
Interval -0.04 to -0.01
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=27 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Haematocrit Changes
|
-0.02 Ratio
Interval -0.03 to 0.0
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in liver enzymes
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SGOT/AST Changes
|
-14.21 U/l
Interval -30.57 to 2.14
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in liver enzymes
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SGOT/AST Changes
|
-5.46 U/l
Interval -12.85 to 1.92
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in liver enzymes
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SGPT/ALT Changes
|
-16.64 U/l
Interval -42.76 to 9.47
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in liver enzymes
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SGPT/ALT Changes
|
-6.46 U/l
Interval -17.54 to 4.61
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in liver enzymes
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Bilirubin Changes
|
0.16 mg/dl
Interval 0.02 to 0.31
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in liver enzymes
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Bilirubin Changes
|
0.17 mg/dl
Interval 0.03 to 0.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=13 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
CRP Changes
|
0.69 mg/l
Interval -4.2 to 5.59
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=27 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
CRP Changes
|
3.12 mg/l
Interval -1.02 to 7.27
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Sodium Changes
|
0.14 mmol/l
Interval -1.09 to 1.38
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in laboratory parameters
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Sodium Changes
|
0.36 mmol/l
Interval -0.58 to 1.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in renal parameters
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Urea Changes
|
3.43 mg/dl
Interval 0.49 to 6.37
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in renal parameters
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Urea Changes
|
-1.50 mg/dl
Interval -5.39 to 2.39
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in renal parameters
Outcome measures
| Measure |
Riociguat Group
n=14 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Creatinine Changes
|
0.04 mg/dl
Interval -0.4 to 0.12
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in renal parameters
Outcome measures
| Measure |
Riociguat Group
n=12 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Creatinine Clearance Changes
|
-4.00 ml/min
Interval -13.7 to 5.71
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in renal parameters
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Creatinine Changes
|
0.03 mg/dl
Interval -0.02 to 0.08
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Change in renal parameters
Outcome measures
| Measure |
Riociguat Group
n=27 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Creatinine Clearance Changes
|
-0.95 ml/min
Interval -6.75 to 4.84
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=13 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in IVC Collapse
|
4.85 percent
Interval -6.93 to 16.62
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
echocardiographic analysis
Outcome measures
| Measure |
Riociguat Group
n=24 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in IVC Collapse
|
1.38 percent
Interval -8.32 to 11.07
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Physical Functioning
|
3.21 Scores on a scale
Interval -2.4 to 8.83
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Physical Role Function
|
4.46 Scores on a scale
Interval -9.76 to 18.69
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Pain
|
-5.57 Scores on a scale
Interval -13.86 to 2.72
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: General Health Perception
|
0.93 Scores on a scale
Interval -6.42 to 8.28
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Vitality
|
0.71 Scores on a scale
Interval -4.23 to 5.66
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Social Functioning
|
5.79 Scores on a scale
Interval -4.4 to 15.97
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Emotional Role Function
|
-9.54 Scores on a scale
Interval -26.36 to 7.29
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Mental Well-being
|
4.14 Scores on a scale
Interval -2.99 to 11.28
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Physical Summation Score
|
0.79 Scores on a scale
Interval -4.22 to 5.79
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=28 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Mental Summation Score
|
0.50 Scores on a scale
Interval -6.2 to 7.2
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Physical Functioning
|
1.00 Scores on a scale
Interval -8.94 to 10.94
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Physical Role Function
|
1.67 Scores on a scale
Interval -14.43 to 17.77
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Pain
|
3.00 Scores on a scale
Interval -10.46 to 16.46
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: General Health Perception
|
6.33 Scores on a scale
Interval -0.63 to 13.29
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Vitality
|
-2.33 Scores on a scale
Interval -8.15 to 3.48
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Social Functioning
|
9.13 Scores on a scale
Interval -1.13 to 19.39
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Emotional Role Function
|
-13.27 Scores on a scale
Interval -36.18 to 9.64
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Mental Well-being
|
2.40 Scores on a scale
Interval -6.88 to 11.68
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Physical Summation Score
|
1.80 Scores on a scale
Interval -5.08 to 8.68
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPopulation: All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed participants may vary due to missing data for specific outcome measures.
Measure Description: Quality of Life (QoL) was assessed using the SF 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated.
Outcome measures
| Measure |
Riociguat Group
n=15 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
SF-36: Mental Summation Score
|
0.53 Scores on a scale
Interval -6.91 to 7.98
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Thus the analysis was only possible for a reduced number of participants.
Change in Cardiopulmonary Exercise testing
Outcome measures
| Measure |
Riociguat Group
n=10 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Consumption Per kg Body Weight (VO2/kg)
VO2/kg at anaerobic threshold
|
3.51 ml/min/kg
Interval 0.24 to 6.79
|
|
Change in Oxygen Consumption Per kg Body Weight (VO2/kg)
VO2/kg at rest
|
-0.90 ml/min/kg
Interval -1.63 to -0.17
|
|
Change in Oxygen Consumption Per kg Body Weight (VO2/kg)
VO2/kg at peak workload
|
2.15 ml/min/kg
Interval 0.42 to 3.87
|
SECONDARY outcome
Timeframe: Baseline to 12weeksPopulation: CPET was not feasible in most cases because of COVID-19 restrictions and technical issues. Additionally, visit 2 was skipped for several patients which further reduced the number of evaluable patients. Thus the analysis was only possible for a reduced number of participants.
Change in cardiopulmonary exercise testing
Outcome measures
| Measure |
Riociguat Group
n=2 Participants
Riociguat oral tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation.
|
|---|---|
|
Change in Oxygen Consumption Per kg Body Weight (VO2/kg)
VO2/kg at rest
|
-0.45 ml/min/kg
Standard Deviation 1.13
|
|
Change in Oxygen Consumption Per kg Body Weight (VO2/kg)
VO2/kg at anaerobic threshold
|
-1.34 ml/min/kg
Standard Deviation 7.88
|
|
Change in Oxygen Consumption Per kg Body Weight (VO2/kg)
VO2/kg at peak workload
|
3.61 ml/min/kg
Standard Deviation 2.26
|
SECONDARY outcome
Timeframe: baseline to 24 weeksPopulation: RVOT VTI was a pre-specified echocardiographic parameter; however, it was not collected or analyzed in this study due to inherent technical limitations of the echocardiography system used at the study site. As a result, no RVOT VTI data were available for analysis.
echocardiographic analysis
Outcome measures
Outcome data not reported
Adverse Events
Riociguat
Serious adverse events
| Measure |
Riociguat
n=30 participants at risk
Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study. Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks. Study medication will be provided orally with or without food. Tablets should be taken three times daily approximately 6 to 8 hours apart.
|
|---|---|
|
Cardiac disorders
Fluid overload
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Eye disorders
Vitreous hemorrhage
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Eye disorders
Corneal edema
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Infections and infestations
Respiratory infection
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Infections and infestations
Infection with hypoxemia
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Respiratory, thoracic and mediastinal disorders
PAH progression
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
Other adverse events
| Measure |
Riociguat
n=30 participants at risk
Riociguat (1 mg, 1.5 mg, 2 mg and 2.5 mg three times daily) starting at 1.0 mg three times daily at the beginning of the study. Dosage will be individually up-titrated up to a maximum dosage of 2.5 mg three times daily after 8 weeks. Study medication will be provided orally with or without food. Tablets should be taken three times daily approximately 6 to 8 hours apart.
|
|---|---|
|
Cardiac disorders
Edema
|
16.7%
5/30 • Number of events 5 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Cardiac disorders
Unspecified circulatory system disorder
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Gastrointestinal disorders
Heartburn
|
43.3%
13/30 • Number of events 18 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
General disorders
Fatigue
|
13.3%
4/30 • Number of events 4 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Infections and infestations
Covid-19
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Infections and infestations
Respiratory infection
|
20.0%
6/30 • Number of events 11 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Metabolism and nutrition disorders
Vitamin D defiency
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
6.7%
2/30 • Number of events 4 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
13.3%
4/30 • Number of events 4 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Nervous system disorders
Headache
|
23.3%
7/30 • Number of events 7 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Psychiatric disorders
Sleep disorders
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10 • Number of events 3 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.7%
8/30 • Number of events 10 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Vascular disorders
Epistaxis
|
6.7%
2/30 • Number of events 2 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Cardiac disorders
Hypotension
|
16.7%
5/30 • Number of events 5 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Cardiac disorders
Dizziness
|
23.3%
7/30 • Number of events 7 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Cardiac disorders
Palpitation
|
16.7%
5/30 • Number of events 7 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
|
Cardiac disorders
Tachycardia
|
6.7%
2/30 • Number of events 4 • Adverse event data were collected from baseline until safety follow-up (30 ± 14 days after last intake of study drug), up to 7 months from baseline.
|
Additional Information
Prof. Dr. med. Ekkehard Grünig
Thoraxklinik Heidelberg gGmbH
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place