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

Not Applicable
Terminated
Conditions
Heart Failure
Interventions
Device: Weight monitoring
Drug: 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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Loop diuretic downtitrationWeight monitoringScheduled downtitration of maintenance loop diuretic dose while monitoring weight
Loop diuretic downtitrationLoop diuretic downtitrationScheduled downtitration of maintenance loop diuretic dose while monitoring weight
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Number of Participants Rehospitalized for Heart Failure30 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 Mortality30 days after baseline
Number of Participants Requiring a Dose Increase in Loop Diuretics30 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 Change7 days after baseline

Weight change \[kg\] 7 days after baseline compared to baseline weight.

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg

🇧🇪

Genk, Limburg, Belgium

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