Spot Urinary Analysis to Assess Loop Diuretic Efficiency in Stable Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Diuretic Efficiency in Patients With Stable Heart Failure: Ion Excretion Capacity of the Kidneys (DIPSTICK) Study

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Weight monitoring
* Drug: Loop diuretic downtitration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Loop diuretic downtitration<br>Scheduled downtitration of maintenance loop diuretic dose while monitoring weight | Device: Weight monitoring<br>* The body weight of patients is measured each morning in identical conditions on the same balance during 7 days<br>Drug: Loop diuretic downtitration<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause Mortality |  | 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. | 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. | 30 days after baseline | 
| Weight Change | Weight change [kg] 7 days after baseline compared to baseline weight. | 7 days after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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loop diuretics, heart failure, natriuresis, urinary analysis