Safety and Efficacy of the Combination of Loop With Thiazide-type Diuretics in Patients With Decompensated Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2019-12-15

Brief Summary

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The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid overload symptoms) among patients with decompensated heart failure in comparison with loop diuretic alone.

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Detailed Description

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Volume overload is an important clinical target in heart failure management, typically addressed using loop diuretics. An important and challenging subset of heart failure patients exhibit fluid overload despite significant doses of loop diuretics. One approach to overcome loop diuretic resistance is the addition of a thiazide-type diuretic to produce diuretic synergy via "sequential nephron blockade," first described more than 40 years ago. Although potentially able to induce diuresis in patients otherwise resistant to high doses of loop diuretics, this strategy has not been subjected to large-scale clinical trials to establish safety and clinical efficacy. Combination diuretic therapy using any of several thiazide-type diuretics can more than double daily urine sodium excretion to induce weight loss and edema resolution. To our knowledge there are no clinical trials designed to prove the efficacy and safety of combined diuretic therapy (a commonly used therapy) among patients with decompensated heart failure.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Loop plus thiazide-type diuretic

Loop diuretic plus hydrochlorothiazide

Group Type ACTIVE_COMPARATOR

hydrochlorothiazide

Intervention Type DRUG

hydrochlorothiazide according to clearance of creatinine; \>50ml/min 25mg daily, 20-50ml/min 50mg daily amd \<20ml/min 100mg daily.

Loop diuretic plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo according to clearance of creatinine; \>50ml/min 1/2 pill daily, 20-50ml/min 1 pill daily amd \<20ml/min 2 pills daily.

Interventions

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hydrochlorothiazide

hydrochlorothiazide according to clearance of creatinine; \>50ml/min 25mg daily, 20-50ml/min 50mg daily amd \<20ml/min 100mg daily.

Intervention Type DRUG

Placebo

Placebo according to clearance of creatinine; \>50ml/min 1/2 pill daily, 20-50ml/min 1 pill daily amd \<20ml/min 2 pills daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of chronic heart failure
* Admission for acute decompensated heart failure
* There is no prespecified inclusion criterion with respect to heart failure etiology and/or ejection fraction
* Receipt of an oral loop diuretic for at least 1 month before hospitalization, at a dose between 80 mg and 240 mg daily in the case of furosemide and an equivalent dose in the case of a different loop diuretic (20 mg of torasemide or 1 mg of bumetanide was considered to be equivalent to 40 mg of furosemide)

Exclusion Criteria

* Other etiologies of fluid overload different from heart failure
* Hyponatremia: any symptomatic sodium value or a sodium level below 125mmol/l
* Unstable patients: acute coronary syndrome, cardiogenic shock or ICU admission.
* Patients requiring inotropic agents or renal replacement therapies
* Life expectancy \< 6 months
* Prior treatment with thiazide-type diuretics
* Aldosterone antagonists are permitted if the patient had been taking them on a long-term basis (at least 30 days before randomisation)
* Pregnancy or breastfeeding period
* Active alcoholism and/or other substance abuse

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No