Trial Outcomes & Findings for Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure (NCT NCT02288819)
NCT ID: NCT02288819
Last Updated: 2019-04-16
Results Overview
After baseline evaluation, loop diuretics are temporarily downtitrated or stopped for 7 consecutive days. The patient is instructed to measure his/her weight in the morning of these days, immediately after waking up, on the same balance. In case of weight increase \>1,5 kg, the original dose of diuretics is restored. To check this, patients are contacted by phone after 3 and 7 days. If the patient has not gained \>1,5 kg of weight after 7 days, loop diuretics are considered to be successfully downtitrated.
TERMINATED
NA
50 participants
7 days after baseline
2019-04-16
Participant Flow
Outpatient cardiology clinic of a single tertiary centre (Ziekenhuis Oost-Limburg, Genk, Belgium) between December, 2014, and February, 2016.
Participant milestones
| Measure |
Loop Diuretic Downtitration
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure
Baseline characteristics by cohort
| Measure |
Loop Diuretic Downtitration
n=50 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
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|---|---|
|
Age, Continuous
|
73 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Belgium
|
50 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 7 days after baselineAfter baseline evaluation, loop diuretics are temporarily downtitrated or stopped for 7 consecutive days. The patient is instructed to measure his/her weight in the morning of these days, immediately after waking up, on the same balance. In case of weight increase \>1,5 kg, the original dose of diuretics is restored. To check this, patients are contacted by phone after 3 and 7 days. If the patient has not gained \>1,5 kg of weight after 7 days, loop diuretics are considered to be successfully downtitrated.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=50 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
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|---|---|
|
Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)
|
37 Participants
|
SECONDARY outcome
Timeframe: 30 days after baselineOutcome measures
| Measure |
Loop Diuretic Downtitration
n=50 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
All-cause Mortality
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after baselineUnplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=50 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Number of Participants Rehospitalized for Heart Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after baselineDose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=50 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Number of Participants Requiring a Dose Increase in Loop Diuretics
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 days after baselineWeight change \[kg\] 7 days after baseline compared to baseline weight.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=50 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Weight Change
|
0.502 kg
Standard Deviation 1.101
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselineWeight change \[kg\] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics).
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=43 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Weight Change
|
-0.261 kg
Standard Deviation 1.391
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselinePopulation: 1 patient who died before the 30-day follow-up could not be assessed
The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=49 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Self-reported Orthopnea
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselinePopulation: 1 patient who died before the 30-day follow-up could not be assessed
The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=49 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Self-reported Lower Leg Edema
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselinePopulation: 1 patient who died before the 30-day follow-up could not be assessed
NYHA class is a semi-quantitative measurement of functional capacity on a scale from 1 to 4: 1. No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). 2. Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath). 3. Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea. 4. Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. For the purpose of this outcome parameter, the patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.
Outcome measures
| Measure |
Loop Diuretic Downtitration
n=49 Participants
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
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|---|---|
|
New York Heart Association (NYHA) Functional Class
|
1.41 units on a scale from 1 to 4
Standard Deviation 0.57
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after baselinePopulation: The study was terminated after every participant reached the 30-day follow-up point because of slow recruitment and a lack of funding to complete further follow-up
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after baselineUnplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after baselineDose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 days after baselineWeight change \[kg\] 7 days after baseline compared to baseline weight.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselineThe patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselineThe patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days after baselineThe patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.
Outcome measures
Outcome data not reported
Adverse Events
Loop Diuretic Downtitration
Serious adverse events
| Measure |
Loop Diuretic Downtitration
n=50 participants at risk
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Weight monitoring: The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
Loop diuretic downtitration: The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
In case of a total daily maintenance dose \>40 mg furosemide OR \>1 mg bumetanide OR \>20 mg torsemide, the loop diuretic dose is halved.
|
|---|---|
|
Cardiac disorders
Heart failure readmission
|
2.0%
1/50 • Number of events 1 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place