European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure

Phase 3

Terminated

• Conditions: Congestive Heart Failure
• Interventions: Drug: Dronedarone (SR33589); Drug: Placebo

• Registration Number: NCT00696631
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2003-01
• Study Completion: 2003-08
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-12
• Last Update Posted: 2010-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 653

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dronedarone 400mg bid	Dronedarone (SR33589)	dronedarone 400mg tablets
Placebo	Placebo	matching placebo tablets

Primary Outcome Measures

Name	Time	Method
Death from any cause or adjudicated hospitalization for worsening heart failure	Until study cut-off date

Trial Locations

Locations (1)

Sanofi-aventis Administrative Office; 🇸🇪 Bromma, Sweden