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

• ClinicalTrials.gov Identifier: NCT01047566
• Recruitment Status: Completed
• First Posted: January 13, 2010
• Last Update Posted: November 10, 2011
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

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 (Clinical Trial)
• 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: April 2010
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 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 Name: 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 :

1. Ventricular rate [ Time Frame: One week ]

Secondary Outcome Measures :

1. Ventricular rate [ Time Frame: 12 weeks ]
2. Patients with registered AF episodes [ Time Frame: Within the 12 weeks after randomization ]
3. Patients with symptomatic AF episodes [ Time Frame: Within the 12 weeks after randomization ]
4. Severity of AF and AF-like symptoms [ Time Frame: Within the 12 weeks after randomization ]
5. Premature study discontinuation [ Time Frame: 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)
6. Patients with symptomatic episodes of bradycardia [ Time Frame: Within the 12 weeks after randomization ]
7. Patients with low heart rate (<60 bpm) [ Time Frame: Within the 12 weeks after randomization ]

Eligibility Criteria

• Ages Eligible for Study: 46 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Netherlands

Sanofi-Aventis Administrative Office

PE Gouda, Netherlands

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Clinical Sciences & Operations; Sanofi

More Information

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT01047566
• Obsolete Identifiers: NCT01117207
• Other Study ID Numbers: DRONE_L_05066; 2009-018215-53 ( EudraCT Number )
• First Posted: January 13, 2010
• Last Update Posted: November 10, 2011
• Last Verified: November 2011

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Digoxin; Dronedarone; Calcium Channel Blockers; Calcium; Adrenergic beta-Antagonists; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Cardiotonic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protective Agents; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Membrane Transport Modulators