European Trial of Dronedarone in Moderate to Severe Congestive 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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

653 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2003-08-31

Brief Summary

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The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular dysfunction (LVD) when added to evidence based treatments for CHF.

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Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dronedarone 400mg bid

dronedarone 400mg tablets

Group Type EXPERIMENTAL

Dronedarone (SR33589)

Intervention Type DRUG

oral administration

Placebo

matching placebo tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral administration

Interventions

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Dronedarone (SR33589)

oral administration

Intervention Type DRUG

Placebo

oral administration

Intervention Type DRUG

Other Intervention Names

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Multaq®

Eligibility Criteria

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Inclusion Criteria

* Patients hospitalized with symptomatic CHF, current New York Heart Association (NYHA) class II-IV requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to NYHA class III or IV
* Wall motion index (WMI) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (LVEF) ≤35%.

Exclusion Criteria

* acute pulmonary edema within 12 hours prior to start of study medication
* various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia \<50 bpm and/or PR-interval ≥280 ms, QTc-interval \>500 ms, significant sinus node disease)
* any illness or disorder other than CHF (cancer with metastasis, organ transplantation)
* current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class I or III anti-arrhythmic drugs
* pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control
* serum potassium \<3.5 mmol/L.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No