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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

653

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Jun 2002

Shorter than P25 for phase_3

Geographic Reach

6 countries

6 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

June 1, 2002

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed

4.9 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed

Last Updated

February 15, 2010

Status Verified

February 1, 2010

Enrollment Period

7 months

First QC Date

June 12, 2008

Last Update Submit

February 12, 2010

Conditions

Congestive Heart Failure

Keywords

Heart diseasemorbidity

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

Dronedarone 400mg bid

EXPERIMENTAL

dronedarone 400mg tablets

Drug: Dronedarone (SR33589)

Placebo

PLACEBO COMPARATOR

matching placebo tablets

Drug: Placebo

Interventions

Dronedarone (SR33589)DRUG

oral administration

Also known as: Multaq®

Dronedarone 400mg bid

PlaceboDRUG

oral administration

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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%.

You may not qualify if:

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.

Contact the study team to confirm eligibility.