Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: Weight monitoringDrug: Loop diuretic downtitration
- Registration Number
- NCT02288819
- Lead Sponsor
- Hasselt University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- Patient has a left ventricular ejection fraction <40% or has been previously hospitalized with a primary diagnosis of heart failure
- Patient receives a daily maintenance dose of loop diuretics
- Patient was hospitalized for heart failure <3 months before study inclusion
- The maintenance dose of loop diuretics was changed <3 months before study inclusion
- The maintenance dose of renin-angiotensin-aldosterone system blockers or beta-blocker medication was changed <3 months before study inclusion
- Cardiac resynchronization therapy (CRT) was initiated <3 months before study inclusion
- At the moment of inclusion, the patient has either one of the following signs of volume overload: lower leg edema +2/4, ascites, lung congestion
- Patient is not able to measure his/her weight safely and correct at home
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Loop diuretic downtitration Weight monitoring Scheduled downtitration of maintenance loop diuretic dose while monitoring weight Loop diuretic downtitration Loop diuretic downtitration Scheduled downtitration of maintenance loop diuretic dose while monitoring weight
- Primary Outcome Measures
Name Time Method Number of Participants With Successful Downtitration of Loop Diuretics (no Weight Increase >1,5 kg) 7 days after baseline 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Rehospitalized for Heart Failure 30 days after baseline Unplanned hospital admission for symptoms of congestion and/or low output heart failure requiring either intravenous therapy and/or increase of oral diuretics.
All-cause Mortality 30 days after baseline Number of Participants Requiring a Dose Increase in Loop Diuretics 30 days after baseline Dose increase of oral maintenance therapy with loop diuretics compared to the final dose achieved in the study 7 days after baseline.
Weight Change 7 days after baseline Weight change \[kg\] 7 days after baseline compared to baseline weight.
Trial Locations
- Locations (1)
Ziekenhuis Oost-Limburg
🇧🇪Genk, Limburg, Belgium