Clinical trial NCT00696631: European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure
Official title: Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Congestive Heart Failure
Keywords: Heart disease
morbidity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 653
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Death from any cause or adjudicated hospitalization for worsening heart failure
timeFrame: Until study cut-off date
Secondary outcomes:
Other outcomes:
Locations:
city: Horsholm
country: Denmark
facility: Sanofi-aventis Administrative Office
city: Budapest
country: Hungary
facility: Sanofi-aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-aventis Administrative Office
city: Lysaker
country: Norway
facility: Sanofi-aventis Administrative Office
city: Warszawa
country: Poland
facility: Sanofi-aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD
role: STUDY_DIRECTOR
References:
citation: Kober L, Torp-Pedersen C, McMurray JJ, Gotzsche O, Levy S, Crijns H, Amlie J, Carlsen J; Dronedarone Study Group. Increased mortality after dronedarone therapy for severe heart failure. N Engl J Med. 2008 Jun 19;358(25):2678-87. doi: 10.1056/NEJMoa0800456.