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

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Sanofi

Status and phase

Terminated
Phase 3

Conditions

Congestive Heart Failure

Treatments

Drug: Dronedarone (SR33589)
Drug: Placebo

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

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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