European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure

Study Overview
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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.

Official Title
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Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: Dronedarone (SR33589)
* Drug: Placebo


Participation Criteria
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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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dronedarone 400mg bid<br>dronedarone 400mg tablets | Drug: Dronedarone (SR33589)<br>* oral administration<br>* Other names: Multaq®;|
| Placebo Comparator: Placebo<br>matching placebo tablets | Drug: Placebo<br>* oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death from any cause or adjudicated hospitalization for worsening heart failure |  | Until study cut-off date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart disease, morbidity