Atrial Fibrillation
Conditions
Brief 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)
Interventions
DRUGDronedarone
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)
DRUGBeta blocker or calcium antagonist or digoxin
Dose increase of beta blocker or calcium antagonist or digoxin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
46 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Persistent AF 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 * Anticoagulant treatment in line with local guidelines
Exclusion criteria
* Incapacitated patients * Paroxysmal or permanent AF * Use of class I or III anti-arrhythmic drugs in the past 12 weeks * Scheduled cardioversion or pulmonary vein ablation * Unstable New York Heart Association (NYHA) class III and all class IV Heart Failure * AV block grade 2 or 3 * Known severe renal impairment (serum creatinine \> 180 μmol/l) * Known severe hepatic impairment (AST, ALT \> 3 x Upper Limit of Normal (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 * Lactating women The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ventricular rate | One week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients with registered AF episodes | Within the 12 weeks after randomization | — |
| Patients with symptomatic AF episodes | Within the 12 weeks after randomization | — |
| Severity of AF and AF-like symptoms | Within the 12 weeks after randomization | — |
| Ventricular rate | 12 weeks | — |
| Patients with symptomatic episodes of bradycardia | Within the 12 weeks after randomization | — |
| Patients with low heart rate (<60 bpm) | Within the 12 weeks after randomization | — |
| Premature study discontinuation | Within the 12 weeks after randomization | 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) |
Countries
Netherlands
Outcome results
None listed