Trial Outcomes & Findings for BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF (NCT NCT04434664)
NCT ID: NCT04434664
Last Updated: 2026-01-30
Results Overview
The difference in home systolic blood pressure between treatments was determined using a single summary value per participant per intervention period, calculated as the mean of all available home systolic BP readings obtained during the final week of each intervention period. Home BP monitoring was performed using the same validated device model (Microlife BP 3MX1-4 WatchBP Home N), with three consecutive measurements taken in the morning and evening each day over the seven-day period.
COMPLETED
PHASE4
50 participants
Measured during the last week of each of the two 4-week intervention phases
2026-01-30
Participant Flow
Participant milestones
| Measure |
Amlodipine Besylate, Then Metoprolol Succinate
Drug: Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
Drug: Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
|
Metoprolol Succinate, Then Amlodipine Besylate
Drug: Metoprolol succinate, initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
Drug: Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
|
|---|---|---|
|
First Intervention (4 weeks)
STARTED
|
25
|
25
|
|
First Intervention (4 weeks)
COMPLETED
|
23
|
22
|
|
First Intervention (4 weeks)
NOT COMPLETED
|
2
|
3
|
|
Washout (one week)
STARTED
|
23
|
22
|
|
Washout (one week)
COMPLETED
|
23
|
22
|
|
Washout (one week)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4 weeks)
STARTED
|
23
|
22
|
|
Second Intervention (4 weeks)
COMPLETED
|
23
|
22
|
|
Second Intervention (4 weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BLOCKade of Calcium Channels and Beta Adrenergic Receptors for the Treatment of Hypertension in HFpEF
Baseline characteristics by cohort
| Measure |
Amlodipine Besylate, Then Metoprolol Succinate
n=25 Participants
Drug: Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
Drug: Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
|
Metoprolol Succinate, Then Amlodipine Besylate
n=25 Participants
Drug: Metoprolol succinate, initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
Drug: Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 10 • n=41 Participants
|
73 years
STANDARD_DEVIATION 9 • n=1581 Participants
|
72 years
STANDARD_DEVIATION 9 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=41 Participants
|
21 Participants
n=1581 Participants
|
34 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
16 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=41 Participants
|
18 Participants
n=1581 Participants
|
33 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
17 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=41 Participants
|
25 Participants
n=1581 Participants
|
49 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Office Systolic Blood Pressure
|
145 mm Hg
STANDARD_DEVIATION 15 • n=41 Participants
|
142 mm Hg
STANDARD_DEVIATION 14 • n=1581 Participants
|
144 mm Hg
STANDARD_DEVIATION 15 • n=4626 Participants
|
|
Office Diastolic Blood Pressure
|
79 mm Hg
STANDARD_DEVIATION 11 • n=41 Participants
|
77 mm Hg
STANDARD_DEVIATION 7 • n=1581 Participants
|
78 mm Hg
STANDARD_DEVIATION 9 • n=4626 Participants
|
|
New York Heart Association Class
Class II
|
20 Participants
n=41 Participants
|
21 Participants
n=1581 Participants
|
41 Participants
n=4626 Participants
|
|
New York Heart Association Class
Class III
|
5 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
|
N-terminal Pro-B-type Natriuretic Peptide
|
97 pg/mL
n=41 Participants
|
100 pg/mL
n=1581 Participants
|
97 pg/mL
n=4626 Participants
|
|
Septal E/e'
|
13 ratio
STANDARD_DEVIATION 4 • n=41 Participants
|
14 ratio
STANDARD_DEVIATION 4 • n=1581 Participants
|
14 ratio
STANDARD_DEVIATION 4 • n=4626 Participants
|
|
Kansas City Cardiomyopathy Questionnaire
|
68 score
STANDARD_DEVIATION 25 • n=41 Participants
|
68 score
STANDARD_DEVIATION 22 • n=1581 Participants
|
68 score
STANDARD_DEVIATION 23 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Measured during the last week of each of the two 4-week intervention phasesThe difference in home systolic blood pressure between treatments was determined using a single summary value per participant per intervention period, calculated as the mean of all available home systolic BP readings obtained during the final week of each intervention period. Home BP monitoring was performed using the same validated device model (Microlife BP 3MX1-4 WatchBP Home N), with three consecutive measurements taken in the morning and evening each day over the seven-day period.
Outcome measures
| Measure |
Amlodipine Besylate
n=45 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=45 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Home Systolic Blood Pressure
|
130.7 mm Hg
Standard Deviation 12.4
|
134.5 mm Hg
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Measured during the last week of each of the two 4-week intervention phasesThe difference in home diastolic blood pressure between treatments was determined using a single summary value per participant per intervention period, calculated as the mean of all available home diastolic BP readings obtained during the final week of each intervention period. Home BP monitoring was performed using the same validated device model (Microlife BP 3MX1-4 WatchBP Home N), with three consecutive measurements taken in the morning and evening each day over the seven-day period.
Outcome measures
| Measure |
Amlodipine Besylate
n=45 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=45 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Home Diastolic Blood Pressure
|
73.5 mm Hg
Standard Deviation 7.6
|
74.1 mm Hg
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Two individuals did not complete their final study visit/did not provide sufficient data to calculate the final estimate
Blood pressure will be measured at rest with a validated oscillometric device (Uscom BP+/UM-211).
Outcome measures
| Measure |
Amlodipine Besylate
n=43 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=43 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Office Systolic Blood Pressure
|
133.4 mm Hg
Standard Deviation 32.6
|
135.9 mm Hg
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Two individuals did not complete their final study visit/did not provide sufficient data to calculate the final estimate
Blood pressure will be measured at rest with a validated oscillometric device (Uscom BP+/UM-211).
Outcome measures
| Measure |
Amlodipine Besylate
n=43 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=43 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Office Diastolic Blood Pressure
|
72.4 mm Hg
Standard Deviation 11.2
|
73.0 mm Hg
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Eight individuals did not complete exercise testing during at least one of their endpoint visits
We will use a supine cycle ergometer in conjunction with expired gas analysis to assess oxygen consumption (VO2) during exercise. Subjects will perform a maximal exertion-limited exercise test using a graded-exercise protocol.
Outcome measures
| Measure |
Amlodipine Besylate
n=37 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=37 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Peak Oxygen Consumption (VO2) During a Maximal Exercise Test
|
12.2 ml/min/kg
Standard Deviation 3.8
|
10.8 ml/min/kg
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: One individual was unable to complete the questionnaire at one of their endpoint visits
Quality of life will be assessed with the Kansas City Cardiomyopathy Questionnaire. The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100. The total score will be calculated as the mean of the three subscale scores. A mean score of 100 represents the least symptoms and 0 represents the worst symptoms.
Outcome measures
| Measure |
Amlodipine Besylate
n=44 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=44 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Quality of Life
|
67 score on a scale
Standard Deviation 22
|
68 score on a scale
Standard Deviation 24
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Ten individuals did not complete the necessary exercise testing and/or echocardiography during at least one endpoint visit
Systemic vascular resistance (SVR) will be calculated at rest and at peak exercise as mean arterial pressure / cardiac output. Systemic vasodilatory reserve will be measured as the percentage reduction in SVR during exercise, relative to SVR at rest (\[rest SVR - peak exercise SVR\] / rest SVR) x 100%.
Outcome measures
| Measure |
Amlodipine Besylate
n=35 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=35 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Systemic Vasodilatory Response to Exercise
|
20 Percentage reduction
Standard Deviation 14
|
25 Percentage reduction
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: 6 individuals did not have the necessary tonometry readings captured during at least one endpoint visit
Arterial wave reflections will be assessed using radial artery pressure waveforms obtained with a high-fidelity applanation tonometer. Waveforms will be calibrated using brachial mean and diastolic blood pressure. Forward and backward pressure wave components will be derived using wave separation analysis, and arterial wave reflection magnitude will be quantified as the ratio of backward to forward pressure wave amplitudes (unitless ratio). Change from baseline will be reported.
Outcome measures
| Measure |
Amlodipine Besylate
n=39 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=39 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Arterial Wave Reflections
|
0.5 ratio of backward to forward waveforms
Standard Deviation 0.10
|
0.5 ratio of backward to forward waveforms
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Six individuals did not complete the necessary tonometry measurements during at least one endpoint visit
Large artery stiffness will be assessed by measuring carotid-femoral pulse wave velocity using arterial applanation tonometry. Pulse wave velocity will be calculated as the distance between the carotid and femoral recording sites divided by the transit time of the arterial pressure waveform.
Outcome measures
| Measure |
Amlodipine Besylate
n=39 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=39 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Large Artery Stiffness
|
11 m/s
Standard Deviation 5
|
10 m/s
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Three individuals did not complete the necessary echocardiographic measurements during at least one endpoint visit
We will assess the ratio of early diastolic mitral inflow velocity (E) to mitral annular tissue velocity (e'; a surrogate of LV filling pressures) on echocardiography
Outcome measures
| Measure |
Amlodipine Besylate
n=42 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=42 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Left Ventricular Filling Pressure
|
14 ratio of E/e'
Standard Deviation 5
|
15 ratio of E/e'
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Measured at the end of each of the two 4-week intervention phasesPopulation: Twelve individuals did not have the necessary echocardiographic measurements performed during at least one study visit
Left ventricular systolic function will be assessed by global longitudinal myocardial strain measured using two-dimensional speckle-tracking echocardiography. Strain will be calculated as the peak systolic percentage change in myocardial length from end-diastole to end-systole, expressed as a percentage.
Outcome measures
| Measure |
Amlodipine Besylate
n=33 Participants
Amlodipine besylate, initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=33 Participants
Metoprolol succinate. Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
|---|---|---|
|
Difference in Myocardial Strain
|
-19 Percentage change in length
Standard Deviation 3
|
-20 Percentage change in length
Standard Deviation 2
|
Adverse Events
Amlodipine Besylate
Metoprolol Succinate
Serious adverse events
| Measure |
Amlodipine Besylate
n=45 participants at risk
Initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=46 participants at risk
Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
|
|---|---|---|
|
Cardiac disorders
Syncope
|
2.2%
1/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
0.00%
0/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
Other adverse events
| Measure |
Amlodipine Besylate
n=45 participants at risk
Initial dose 5mg (1 capsule) daily, titrated up to 10mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use.
|
Metoprolol Succinate
n=46 participants at risk
Initial dose 100mg (1 capsule) daily, titrated up to 200mg (2 capsules) daily for a home systolic BP ≥135 mmHg and heart rate ≥50 bpm after the first week of use
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.4%
2/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
4.3%
2/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Fatigue at rest
|
13.3%
6/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
6.5%
3/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Leg swelling
|
6.7%
3/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
2.2%
1/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Nervous system disorders
Lightheadedness
|
4.4%
2/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
10.9%
5/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
4.3%
2/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
2.2%
1/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Cramping or pain
|
11.1%
5/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
13.0%
6/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
10.9%
5/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Renal and urinary disorders
Abnormal serum calcium
|
6.7%
3/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
2.2%
1/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia (spO2 90-94%) or dyspnea
|
4.4%
2/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
4.3%
2/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Hepatobiliary disorders
Rising liver enzymes
|
4.4%
2/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
6.5%
3/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Chest pain
|
2.2%
1/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
4.3%
2/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Gastrointestinal disorders
Loose stools
|
6.7%
3/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
6.5%
3/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Bradycardia
|
6.7%
3/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
13.0%
6/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Arrhythmia
|
11.1%
5/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
2.2%
1/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Low blood pressure
|
13.3%
6/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
6.5%
3/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
High blood pressure
|
6.7%
3/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
19.6%
9/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Cardiac disorders
Worsening heart failure
|
13.3%
6/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
15.2%
7/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
|
Renal and urinary disorders
Worsening kidney function
|
6.7%
3/45 • From enrollment until the end of follow-up, an average of 10 weeks
|
2.2%
1/46 • From enrollment until the end of follow-up, an average of 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place