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

Phase 4

Completed

Conditions: 10007521
atrial fibrillation
irregular heart beat

Registration Number: NL-OMON36263

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 596

Inclusion Criteria

• Paroxysmal 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 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.

Exclusion Criteria

• Incapacitated patients.
• Permanent AF (according to ACC/AHA/ESC 2006 definition).
• Use of class I or III AADs in the past 3 months.
• 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Ventricular rate after 1 week.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Ventricular rate after 3 months.<br /><br>- Number of registered AF episodes.<br /><br>- Number of symptomatic AF episodes.<br /><br>- Severity of AF and AF-like symptoms.<br /><br>- Adverse events.<br /><br>- Rate of premature study discontinuation (going off study prematurely).<br /><br>- Number of symptomatic episodes of bradycardia.<br /><br>- Incidence of low heart rate (<60 bpm).</p><br>