Effect of Addition of Dronedarone to Standard Rate Control Therapy on Ventricular Rate During Persistent Atrial Fibrillation (AFRODITE)
- Conditions
- Atrial Fibrillation
- Interventions
- Drug: Beta blocker or calcium antagonist or digoxin
- Registration Number
- NCT01047566
- Lead Sponsor
- Sanofi
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose Increase Beta blocker or calcium antagonist or digoxin Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin) Addition of dronedarone Dronedarone Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)
- Primary Outcome Measures
Name Time Method Ventricular rate One week
- Secondary Outcome Measures
Name Time Method Ventricular rate 12 weeks Patients with registered AF episodes Within the 12 weeks after randomization Patients with symptomatic episodes of bradycardia 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 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)
Patients with low heart rate (<60 bpm) Within the 12 weeks after randomization
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇳🇱PE Gouda, Netherlands