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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
183
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)
Dose increase of beta blocker or calcium antagonist or digoxin
Sanofi-Aventis Administrative Office
PE Gouda, Netherlands
Ventricular rate
Time frame: One week
Ventricular rate
Time frame: 12 weeks
Patients with registered AF episodes
Time frame: Within the 12 weeks after randomization
Patients with symptomatic AF episodes
Time frame: Within the 12 weeks after randomization
Severity of AF and AF-like symptoms
Time frame: Within the 12 weeks after randomization
Premature study discontinuation
Premature study discontinuation for all reasons including those where the patients must go off study prematurely as per protocol (ie. in case of cardioversion during the 1st study week, 2nd cardioversion after the 1st study week, addition of anti-arrhythmic drug, ablation or other surgical AF related intervention)
Time frame: Within the 12 weeks after randomization
Patients with symptomatic episodes of bradycardia
Time frame: Within the 12 weeks after randomization
Patients with low heart rate (<60 bpm)
Time frame: Within the 12 weeks after randomization
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