The effect of the addition of dronedarone to, versus increase of, existing conventional rate control medication on ventricular rate during paroxysmal or persistent atrial fibrillation (AFRODITE study) - AFDRODITE

• Conditions: atrial fibrillation; MedDRA version: 12.1Level: LLTClassification code 10003658Term: Atrial fibrillation; MedDRA version: 12.1Level: PTClassification code 10003658Term: Atrial fibrillation

• Registration Number: EUCTR2009-018215-53-NL
• Lead Sponsor: sanofi-aventis Netherlands

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Paroxysmal or persistent AF (according to ACC/AHA/ESC 2006 definition) with HR >80 bpm at rest despite treatment with =2 rate control agents (i.e. beta blocker and/or calcium antagonist). Patients using digoxin are eligible.
•Documented AF at randomisation or documented AF in the past 24 hours.
•Treated with the following rate control medication:
-beta blocker or
-calcium antagonist or
-beta blocker plus calcium antagonist or
-beta blocker plus digoxin or
-calcium antagonist plus digoxin.
•> 45 years of age.
•Anticoagulant treatment in line with local guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Incapacitated patients.
•Permanent AF (according to ACC/AHA/ESC 2006 definition).
•Use of class I or III AADs.
•Patients scheduled for cardioversion or pulmonary vein ablation.
•Unstable NYHA class III and all class IV HF.
•AV block grade 2 or 3.
•Known severe renal impairment (serum creatinine >180 µmol/l).
•Known severe hepatic impairment (AST, ALT >3x ULN).
•Contra-indication for dronedarone.
•Participation in a clinical drug study in the 3 months prior to inclusion.
•Women of childbearing potential, who do not use adequate contraception (in the opinion of the investigator).
•Lactating women.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified