Trial Outcomes & Findings for Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure (NCT NCT05093621)
NCT ID: NCT05093621
Last Updated: 2024-10-15
Results Overview
All-cause mortality as measured by phone calls at 30 days and 1 year
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
47 participants
Primary outcome timeframe
30 days and one year
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
Furosemide
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Furosemide: Standard of care diuretic
|
Torsemide
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Torsemide: Standard of care diuretic
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
24
|
|
Overall Study
Yale Site Participants
|
18
|
18
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure
Baseline characteristics by cohort
| Measure |
Furosemide
n=23 Participants
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Furosemide: Standard of care diuretic
|
Torsemide
n=24 Participants
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Torsemide: Standard of care diuretic
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 13.85 • n=99 Participants
|
63.20 years
STANDARD_DEVIATION 12.05 • n=107 Participants
|
61.93 years
STANDARD_DEVIATION 12.89 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
24 participants
n=107 Participants
|
47 participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
33.87 kg/m^2
STANDARD_DEVIATION 7.26 • n=99 Participants
|
34.39 kg/m^2
STANDARD_DEVIATION 9.13 • n=107 Participants
|
34.13 kg/m^2
STANDARD_DEVIATION 8.18 • n=206 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
40.26 percentage of blood ejected
STANDARD_DEVIATION 14.94 • n=99 Participants
|
43.40 percentage of blood ejected
STANDARD_DEVIATION 17.68 • n=107 Participants
|
41.87 percentage of blood ejected
STANDARD_DEVIATION 16.26 • n=206 Participants
|
|
LVEF < 40%
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ischemic cardiomyopathy
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Heart Failure hospitalization in the past year
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Number of participants with comorbid conditions
Hypertension
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Number of participants with comorbid conditions
Diabetes mellitus
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Number of participants with comorbid conditions
History atrial fibrillation/flutter
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Systolic blood pressure
|
128.91 mmHg
STANDARD_DEVIATION 16.07 • n=99 Participants
|
127.62 mmHg
STANDARD_DEVIATION 17.97 • n=107 Participants
|
128.25 mmHg
STANDARD_DEVIATION 16.89 • n=206 Participants
|
|
Diastolic blood pressure
|
77.43 mmHg
STANDARD_DEVIATION 8.72 • n=99 Participants
|
77.20 mmHg
STANDARD_DEVIATION 10.10 • n=107 Participants
|
77.31 mmHg
STANDARD_DEVIATION 9.35 • n=206 Participants
|
|
Heart rate
|
66.86 beats per minute
STANDARD_DEVIATION 10.95 • n=99 Participants
|
70.73 beats per minute
STANDARD_DEVIATION 9.31 • n=107 Participants
|
68.80 beats per minute
STANDARD_DEVIATION 10.24 • n=206 Participants
|
|
Hypertension drugs
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Beta blocker
|
23 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Mineralocorticoid receptor antagonist
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Daily Dose of prescribed heart medications
|
25 milligrams
n=99 Participants
|
25 milligrams
n=107 Participants
|
25 milligrams
n=206 Participants
|
|
Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Hydralazine & Nitrates
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Chronic oral loop diuretic dose in furosemide equivalents (mg)
|
40 milligrams furosemide equivalents
n=99 Participants
|
40 milligrams furosemide equivalents
n=107 Participants
|
40 milligrams furosemide equivalents
n=206 Participants
|
|
Thiazide
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Serum sodium
|
139.79 mmol/L
STANDARD_DEVIATION 2.59 • n=99 Participants
|
139.86 mmol/L
STANDARD_DEVIATION 3.19 • n=107 Participants
|
139.82 mmol/L
STANDARD_DEVIATION 2.87 • n=206 Participants
|
|
Serum chloride
|
102.88 mmol/L
STANDARD_DEVIATION 2.76 • n=99 Participants
|
101.66 mmol/L
STANDARD_DEVIATION 2.73 • n=107 Participants
|
102.27 mmol/L
STANDARD_DEVIATION 2.78 • n=206 Participants
|
|
Serum potassium
|
4.50 mmol/L
STANDARD_DEVIATION 0.46 • n=99 Participants
|
4.69 mmol/L
STANDARD_DEVIATION 0.53 • n=107 Participants
|
4.59 mmol/L
STANDARD_DEVIATION 0.5 • n=206 Participants
|
|
Serum bicarbonate
|
21.53 mmol/L
STANDARD_DEVIATION 2.83 • n=99 Participants
|
21.98 mmol/L
STANDARD_DEVIATION 3.43 • n=107 Participants
|
21.76 mmol/L
STANDARD_DEVIATION 3.12 • n=206 Participants
|
|
Serum creatinine
|
1.10 mg/dL
STANDARD_DEVIATION 0.43 • n=99 Participants
|
1.21 mg/dL
STANDARD_DEVIATION 0.35 • n=107 Participants
|
1.16 mg/dL
STANDARD_DEVIATION 0.39 • n=206 Participants
|
|
Blood urea nitrogen
|
19.33 mg/dL
STANDARD_DEVIATION 9.66 • n=99 Participants
|
23.54 mg/dL
STANDARD_DEVIATION 8.59 • n=107 Participants
|
21.43 mg/dL
STANDARD_DEVIATION 9.29 • n=206 Participants
|
|
estimated Glomerular Filtration Rate (eGFR)
|
69.51 ml/min/1.73 m^2
STANDARD_DEVIATION 23.13 • n=99 Participants
|
58.84 ml/min/1.73 m^2
STANDARD_DEVIATION 26.38 • n=107 Participants
|
64.06 ml/min/1.73 m^2
STANDARD_DEVIATION 25.16 • n=206 Participants
|
|
eGFR < 60 ml/min/1.73 m^2
|
9 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
eGFR < 30 ml/min/1.73 m^2
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
NT-pro-B-type natriuretic peptide
|
362.5 pg/ml
n=99 Participants
|
1550 pg/ml
n=107 Participants
|
883 pg/ml
n=206 Participants
|
|
Hemoglobin
|
12.58 g/dl
STANDARD_DEVIATION 2.16 • n=99 Participants
|
13.59 g/dl
STANDARD_DEVIATION 2.41 • n=107 Participants
|
13.09 g/dl
STANDARD_DEVIATION 2.32 • n=206 Participants
|
PRIMARY outcome
Timeframe: 30 days and one yearPopulation: Data presented here is from Yale site only. Only data from the Yale site was collected and analyzed. Data from other site could not be collected.
All-cause mortality as measured by phone calls at 30 days and 1 year
Outcome measures
| Measure |
Furosemide
n=18 Participants
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Furosemide: Standard of care diuretic
|
Torsemide
n=18 Participants
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Torsemide: Standard of care diuretic
|
|---|---|---|
|
Number of Participants All-cause Mortality, Measured at 1 Year.
30 days
|
0 Participants
|
0 Participants
|
|
Number of Participants All-cause Mortality, Measured at 1 Year.
one year
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: up to one yearPopulation: Data presented here is from Yale site only. Only data from the Yale site was collected and analyzed. Data from other site could not be collected.
At least one hospitalization for any reason up to one year
Outcome measures
| Measure |
Furosemide
n=18 Participants
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Furosemide: Standard of care diuretic
|
Torsemide
n=18 Participants
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Torsemide: Standard of care diuretic
|
|---|---|---|
|
All-cause Hospitalization
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to one yearPopulation: Data presented here is from Yale site only. Only data from the Yale site was collected and analyzed. Data from other site could not be collected.
Total number of hospitalizations total number of hospitalizations in one year
Outcome measures
| Measure |
Furosemide
n=18 Participants
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Furosemide: Standard of care diuretic
|
Torsemide
n=18 Participants
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Torsemide: Standard of care diuretic
|
|---|---|---|
|
Total Hospitalizations
|
0 hospitalizations
Interval 0.0 to 1.0
|
0 hospitalizations
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: up to one yearPopulation: Data presented here is from Yale site only. Only data from the Yale site was collected and analyzed. Data from other site could not be collected.
Change in weight up to one year
Outcome measures
| Measure |
Furosemide
n=18 Participants
Furosemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Furosemide: Standard of care diuretic
|
Torsemide
n=18 Participants
Torsemide, oral, dosage and frequency determined by treating physician or provider.
1 mg torsemide to 2-4 mg oral furosemide
Torsemide: Standard of care diuretic
|
|---|---|---|
|
Change in Weight
|
-1.84 kilograms
Standard Deviation 4.9
|
-3.04 kilograms
Standard Deviation 10.22
|
Adverse Events
Furosemide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Torsemide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jeffrey Testani, MD, MTR Associate Professor of Medicine
Yale School of Medicine
Phone: (203) 785-7191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place