European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure

Congestive Heart Failure Clinical Trial

— ANDROMEDA  

Official title:

Antiarrhythmic Trial With Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00696631
• Other study ID #: EFC4966
• Secondary ID: SR33589
• Status: Terminated
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: February 12, 2010
• Start date: June 2002
• Est. completion date: August 2003

Study information

• Verified date: February 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00543699

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 653
• Est. completion date: August 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Dronedarone (SR33589)
oral administration
• Placebo
oral administration

Locations

Country	Name	City	State
Denmark	Sanofi-aventis Administrative Office	Horsholm
Hungary	Sanofi-aventis Administrative Office	Budapest
Netherlands	Sanofi-aventis Administrative Office	Gouda
Norway	Sanofi-aventis Administrative Office	Lysaker
Poland	Sanofi-aventis Administrative Office	Warszawa
Sweden	Sanofi-aventis Administrative Office	Bromma

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Denmark,  Hungary,  Netherlands,  Norway,  Poland,  Sweden, 

References & Publications (1)

Køber L, Torp-Pedersen C, McMurray JJ, Gøtzsche O, Lévy 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause or adjudicated hospitalization for worsening heart failure		Until study cut-off date	No