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

Hasselt University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Weight monitoringDEVICE

The body weight of patients is measured each morning in identical conditions on the same balance during 7 days

Loop diuretic downtitrationDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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