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

Sponsor

Sanofi (Industry)

Overall Status

Completed

CT.gov ID

NCT01047566

Collaborator

(none)

183

Enrollment

Location

Arms

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Dronedarone Drug: Beta blocker or calcium antagonist or digoxin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

183 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Effect of the Addition of Dronedarone to, Versus Increase of, Existing Conventional Rate Control Medication on Ventricular Rate During Persistent Atrial Fibrillation

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Addition of dronedarone Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)	Drug: Dronedarone Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days) Other Names: Multaq
Active Comparator: Dose Increase Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)	Drug: Beta blocker or calcium antagonist or digoxin Dose increase of beta blocker or calcium antagonist or digoxin

Arm

Intervention/Treatment

Experimental: Addition of dronedarone

Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)

Drug: Dronedarone

Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)

Other Names:

Multaq

Active Comparator: Dose Increase

Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)

Drug: Beta blocker or calcium antagonist or digoxin

Dose increase of beta blocker or calcium antagonist or digoxin

Outcome Measures

Primary Outcome Measures

Ventricular rate [One week]

Secondary Outcome Measures

Ventricular rate [12 weeks]
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]
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 symptomatic episodes of bradycardia [Within the 12 weeks after randomization]
Patients with low heart rate (<60 bpm) [Within the 12 weeks after randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

46 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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