European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure (ANDROMEDA)

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Congestive Heart Failure

Treatments: Drug: Placebo; Drug: Dronedarone (SR33589)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696631

EFC4966

SR33589

Details and patient eligibility

About

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.

Enrollment: 653 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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653 participants in 2 patient groups, including a placebo group

Dronedarone 400mg bid

Experimental group

Description:

dronedarone 400mg tablets

Treatment:

Drug: Dronedarone (SR33589)

Placebo

Placebo Comparator group

Description:

matching placebo tablets

Treatment:

Drug: Placebo