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=5 Participants
|
63.20 years
STANDARD_DEVIATION 12.05 • n=7 Participants
|
61.93 years
STANDARD_DEVIATION 12.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
33.87 kg/m^2
STANDARD_DEVIATION 7.26 • n=5 Participants
|
34.39 kg/m^2
STANDARD_DEVIATION 9.13 • n=7 Participants
|
34.13 kg/m^2
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Left ventricular ejection fraction (LVEF)
|
40.26 percentage of blood ejected
STANDARD_DEVIATION 14.94 • n=5 Participants
|
43.40 percentage of blood ejected
STANDARD_DEVIATION 17.68 • n=7 Participants
|
41.87 percentage of blood ejected
STANDARD_DEVIATION 16.26 • n=5 Participants
|
|
LVEF < 40%
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ischemic cardiomyopathy
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Heart Failure hospitalization in the past year
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Number of participants with comorbid conditions
Hypertension
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Number of participants with comorbid conditions
Diabetes mellitus
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Number of participants with comorbid conditions
History atrial fibrillation/flutter
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Systolic blood pressure
|
128.91 mmHg
STANDARD_DEVIATION 16.07 • n=5 Participants
|
127.62 mmHg
STANDARD_DEVIATION 17.97 • n=7 Participants
|
128.25 mmHg
STANDARD_DEVIATION 16.89 • n=5 Participants
|
|
Diastolic blood pressure
|
77.43 mmHg
STANDARD_DEVIATION 8.72 • n=5 Participants
|
77.20 mmHg
STANDARD_DEVIATION 10.10 • n=7 Participants
|
77.31 mmHg
STANDARD_DEVIATION 9.35 • n=5 Participants
|
|
Heart rate
|
66.86 beats per minute
STANDARD_DEVIATION 10.95 • n=5 Participants
|
70.73 beats per minute
STANDARD_DEVIATION 9.31 • n=7 Participants
|
68.80 beats per minute
STANDARD_DEVIATION 10.24 • n=5 Participants
|
|
Hypertension drugs
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Beta blocker
|
23 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Mineralocorticoid receptor antagonist
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Daily Dose of prescribed heart medications
|
25 milligrams
n=5 Participants
|
25 milligrams
n=7 Participants
|
25 milligrams
n=5 Participants
|
|
Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
|
5 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Hydralazine & Nitrates
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Chronic oral loop diuretic dose in furosemide equivalents (mg)
|
40 milligrams furosemide equivalents
n=5 Participants
|
40 milligrams furosemide equivalents
n=7 Participants
|
40 milligrams furosemide equivalents
n=5 Participants
|
|
Thiazide
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Serum sodium
|
139.79 mmol/L
STANDARD_DEVIATION 2.59 • n=5 Participants
|
139.86 mmol/L
STANDARD_DEVIATION 3.19 • n=7 Participants
|
139.82 mmol/L
STANDARD_DEVIATION 2.87 • n=5 Participants
|
|
Serum chloride
|
102.88 mmol/L
STANDARD_DEVIATION 2.76 • n=5 Participants
|
101.66 mmol/L
STANDARD_DEVIATION 2.73 • n=7 Participants
|
102.27 mmol/L
STANDARD_DEVIATION 2.78 • n=5 Participants
|
|
Serum potassium
|
4.50 mmol/L
STANDARD_DEVIATION 0.46 • n=5 Participants
|
4.69 mmol/L
STANDARD_DEVIATION 0.53 • n=7 Participants
|
4.59 mmol/L
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Serum bicarbonate
|
21.53 mmol/L
STANDARD_DEVIATION 2.83 • n=5 Participants
|
21.98 mmol/L
STANDARD_DEVIATION 3.43 • n=7 Participants
|
21.76 mmol/L
STANDARD_DEVIATION 3.12 • n=5 Participants
|
|
Serum creatinine
|
1.10 mg/dL
STANDARD_DEVIATION 0.43 • n=5 Participants
|
1.21 mg/dL
STANDARD_DEVIATION 0.35 • n=7 Participants
|
1.16 mg/dL
STANDARD_DEVIATION 0.39 • n=5 Participants
|
|
Blood urea nitrogen
|
19.33 mg/dL
STANDARD_DEVIATION 9.66 • n=5 Participants
|
23.54 mg/dL
STANDARD_DEVIATION 8.59 • n=7 Participants
|
21.43 mg/dL
STANDARD_DEVIATION 9.29 • n=5 Participants
|
|
estimated Glomerular Filtration Rate (eGFR)
|
69.51 ml/min/1.73 m^2
STANDARD_DEVIATION 23.13 • n=5 Participants
|
58.84 ml/min/1.73 m^2
STANDARD_DEVIATION 26.38 • n=7 Participants
|
64.06 ml/min/1.73 m^2
STANDARD_DEVIATION 25.16 • n=5 Participants
|
|
eGFR < 60 ml/min/1.73 m^2
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
eGFR < 30 ml/min/1.73 m^2
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
NT-pro-B-type natriuretic peptide
|
362.5 pg/ml
n=5 Participants
|
1550 pg/ml
n=7 Participants
|
883 pg/ml
n=5 Participants
|
|
Hemoglobin
|
12.58 g/dl
STANDARD_DEVIATION 2.16 • n=5 Participants
|
13.59 g/dl
STANDARD_DEVIATION 2.41 • n=7 Participants
|
13.09 g/dl
STANDARD_DEVIATION 2.32 • n=5 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.
one year
|
0 Participants
|
1 Participants
|
|
Number of Participants All-cause Mortality, Measured at 1 Year.
30 days
|
0 Participants
|
0 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