Trial Outcomes & Findings for A Study of Ultra High Dose Diuretics to Treat Heart Failure (NCT NCT06036914)
NCT ID: NCT06036914
Last Updated: 2026-01-14
Results Overview
The total volume of urine produced in milliliters (mL) over 24 hours after initiation of intravenous diuretic.
COMPLETED
PHASE2
20 participants
24 hours
2026-01-14
Participant Flow
Participant milestones
| Measure |
Ultra-high Dose Diuretic Group
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Ultra-high Dose Diuretic Group
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Ultra High Dose Diuretics to Treat Heart Failure
Baseline characteristics by cohort
| Measure |
Ultra-high Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 12.4 • n=9 Participants
|
70.9 years
STANDARD_DEVIATION 14.3 • n=6 Participants
|
69 years
STANDARD_DEVIATION 13 • n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=9 Participants
|
6 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
20 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=9 Participants
|
9 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=9 Participants
|
10 participants
n=6 Participants
|
20 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 24 hoursThe total volume of urine produced in milliliters (mL) over 24 hours after initiation of intravenous diuretic.
Outcome measures
| Measure |
Ultra-high Dose Diuretic Group
n=9 Participants
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Urine Output
|
5283 mL
Standard Deviation 2976
|
2819 mL
Standard Deviation 1060
|
SECONDARY outcome
Timeframe: Baseline, 24 hoursChange in Body Weight (kg) from Baseline to 24 hours after initiation of intravenous diuretic.
Outcome measures
| Measure |
Ultra-high Dose Diuretic Group
n=9 Participants
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Change in Body Weight
|
-2.6 kg
Standard Deviation 3.0
|
-3.8 kg
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline, 24 hoursChange in NT-proBNP levels (pg/ml) from Baseline to 24 hours after initiation of intravenous diuretic.
Outcome measures
| Measure |
Ultra-high Dose Diuretic Group
n=9 Participants
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Change in NT-proBNP
|
2898 pg/ml
Standard Deviation 7278
|
-1705 pg/ml
Standard Deviation 1712
|
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a results, no data was collected for this outcome measure.
Change in amount of sodium (mmol) excreted in the urine from Baseline to 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep which is an indicator of severity of sleep apnea AHI will be measured using a Watch Pat or Nox device at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
Renal or kidney function was measured by GFR determined by Iohexol clearance. Iohexol GFR will be measured at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data was not collected for 1 subject in the Ultra-High dose diuretic group as the subject requested that peripheral vein pressure data not be collected on them.
Peripheral vein pressure (mm Hg) will be recorded from existing IV lines through pressure transducer monitoring at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
| Measure |
Ultra-high Dose Diuretic Group
n=8 Participants
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Change in Peripheral Vein Pressure
|
-10.9 mmHg
Standard Deviation 7.5
|
-4 mmHg
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data was not technically feasible to obtain for 3 subjects in the Ultra-High Dose diuretic group for this outcome measure.
Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
| Measure |
Ultra-high Dose Diuretic Group
n=6 Participants
Subjects with decompensated heart failure requiring hospitalization received IV bumetanide.
Bumetanide: Bumetanide was administered via intravenous (IV) infusion at a dose of 12.5 mg two times a day (BID) for 2 doses total within 24 hours.
|
Standard Dose Diuretic Group
n=10 Participants
Subjects with decompensated heart failure requiring hospitalization received IV furosemide.
Furosemide: Furosemide was administered via intravenous (IV) infusion at usual doses (twice the home dose of oral daily diuretic in furosemide equivalents) administered as 2 doses total within 24 hours.
Furosemide equivalents were considered as follows (40 mg of intravenous furosemide = 1 mg oral bumetanide or 40 mg of torsemide or 80 mg of oral furosemide consistent with prior literature). The lowest dose of furosemide administered during the study was 40 mg IV two times a day (BID) and the maximum dose was 100 mg IV BID.
|
|---|---|---|
|
Change in Cardiac Output
|
-0.53 L/min
Standard Deviation 0.83
|
0.29 L/min
Standard Deviation 1.50
|
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
Estimated RV systolic pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
RA pressure (mm Hg) will be measured by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
LA strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
LV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
RV global longitudinal strain will be assessed by echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 hoursPopulation: Data for this outcome measure was not collected for any participants. Upon study initiation, this outcome measure was not technically feasible to obtain with existing staffing and was therefore not performed. As a result, no data was collected for this outcome measure.
E/e' will be assessed using echocardiography conducted at Baseline and 24 hours after initiation of intravenous diuretic. It is defined as the ratio of peak early diastolic mitral inflow velocity (E) and peak early diastolic mitral annular velocity (e').
Outcome measures
Outcome data not reported
Adverse Events
Ultra-high Dose Diuretic Group
Standard Dose Diuretic Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place