Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)

• Status: Completed
• Trial end date: 2011-09-01

Summary

The primary objective of this study is to:

Assess whether the addition of dronedarone to existing conventional rate control therapy leads to a reduced ventricular rate after 1 week in patients with a high Heart Rate (HR) at rest during Atrial Fibrillation (AF) in comparison to an increase of conventional therapy.

The secondary objectives of this study are to compare both study arms with regard to:

• Ventricular rate after 3 months

• Number of registered AF episodes

• Number of symptomatic AF episodes

• Severity of AF and AF-like symptoms

• Rate of premature study discontinuation

• Number of symptomatic episodes of bradycardia

• Incidence of low heart rate (<60 bpm)

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Adrenergic beta-Antagonists; Amiodarone; Calcium; Calcium Channel Blockers; Calcium, Dietary; Digoxin; Dronedarone