An interventional study of Weight monitoring and Loop diuretic downtitration in Heart Failure, sponsored by Hasselt University. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by Hasselt University · Not applicable, Interventional, and Treatment
The primary objective of this study is to assess whether the urinary sodium/creatinine or chloride/creatinine ratio might predict successful downtitration of loop diuretics in patients with stable heart failure without clinical signs of volume overload. In addition, this study will provide information on loop diuretic efficiency and urinary electrolyte composition after intake of diuretics in stable outpatients with heart failure.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
Device: Weight monitoring · Drug: Loop diuretic downtitration
The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
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 With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg)
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.
Time frame: 7 days after baseline
All-cause Mortality
Time frame: 30 days after baseline
Number of Participants Rehospitalized for Heart Failure
Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Time frame: 30 days after baseline
Number of Participants Requiring a Dose Increase in Loop Diuretics
Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Time frame: 30 days after baseline
Weight Change
Weight change \[kg\] 7 days after baseline compared to baseline weight.
Time frame: 7 days after baseline
Weight Change
Weight change \[kg\] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics).
Time frame: 30 days after baseline
Self-reported Orthopnea
The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
Time frame: 30 days after baseline
Self-reported Lower Leg Edema
The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.
Time frame: 30 days after baseline
New York Heart Association (NYHA) Functional Class
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.
Time frame: 30 days after baseline
All-cause Mortality
Time frame: 6 months after baseline
Rehospitalization for Heart Failure
Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Time frame: 6 months after baseline
Dose Increase of Loop Diuretics
Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Time frame: 6 months after baseline
Weight Change
Weight change \[kg\] 7 days after baseline compared to baseline weight.
Time frame: 7 days after baseline
NYHA Functional Class
The patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.
Time frame: 30 days after baseline
Outpatient cardiology clinic of a single tertiary centre (Ziekenhuis Oost-Limburg, Genk, Belgium) between December, 2014, and February, 2016.
| Milestone | Loop Diuretic Downtitration |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
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.
| Participants | Loop Diuretic Downtitration |
|---|---|
| Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg) | 37 |
| Participants | Loop Diuretic Downtitration |
|---|---|
| All-cause Mortality | 1 |
Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
| Participants | Loop Diuretic Downtitration |
|---|---|
| Number of Participants Rehospitalized for Heart Failure | 1 |
Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
| Participants | Loop Diuretic Downtitration |
|---|---|
| Number of Participants Requiring a Dose Increase in Loop Diuretics | 1 |
Weight change \[kg\] 7 days after baseline compared to baseline weight.
| kg | Loop Diuretic Downtitration |
|---|---|
| Weight Change | 0.502 ± 1.101 |
Weight change \[kg\] 30 days after baseline compared to weight 7 days after baseline (after achieving the final dose of loop diuretics).
| kg | Loop Diuretic Downtitration |
|---|---|
| Weight Change | -0.261 ± 1.391 |
The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
| Participants | Loop Diuretic Downtitration |
|---|---|
| Self-reported Orthopnea | 5 |
The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.
| Participants | Loop Diuretic Downtitration |
|---|---|
| Self-reported Lower Leg Edema | 1 |
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.
| units on a scale from 1 to 4 | Loop Diuretic Downtitration |
|---|---|
| New York Heart Association (NYHA) Functional Class | 1.41 ± 0.57 |
No measurements were reported for this outcome.
Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
Results for this outcome have not been posted.
Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Results for this outcome have not been posted.
Weight change \[kg\] 7 days after baseline compared to baseline weight.
Results for this outcome have not been posted.
The patient is contacted by phone 30 days after baseline and asked for self-reported orthopnea.
Results for this outcome have not been posted.
The patient is contacted by phone 30 days after baseline and asked for self-reported presence of lower leg edema.
Results for this outcome have not been posted.
The patient is contacted by phone 30 days after baseline and NYHA functional class is assessed by a study investigator.
Results for this outcome have not been posted.
Collected over 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Loop Diuretic Downtitration | 1/50 (2%) | 1/50 (2%) | 0/50 (0%) |
| Event | Loop Diuretic Downtitration |
|---|---|
| Heart failure readmissionCardiac disorders | 1/50 |
| Age, Continuous(years) | Loop Diuretic Downtitration |
|---|---|
| Median | 73 (61 to 78) |
| Sex: Female, Male(Participants) | Loop Diuretic Downtitration |
|---|---|
| Female | 20 |
| Male | 30 |
| Race (NIH/OMB)(Participants) | Loop Diuretic Downtitration |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 50 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Loop Diuretic Downtitration |
|---|---|
| Belgium | 50 |
Plan to share: No
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Hasselt University