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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01047566
First received: January 12, 2010
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Drug: Dronedarone
Drug: Beta blocker or calcium antagonist or digoxin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Ventricular rate [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ventricular rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patients with registered AF episodes [ Time Frame: Within the 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Patients with symptomatic AF episodes [ Time Frame: Within the 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Severity of AF and AF-like symptoms [ Time Frame: Within the 12 weeks after randomization ] [ Designated as safety issue: No ]
  • Premature study discontinuation [ Time Frame: Within the 12 weeks after randomization ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within the 12 weeks after randomization ] [ Designated as safety issue: Yes ]
  • Patients with low heart rate (<60 bpm) [ Time Frame: Within the 12 weeks after randomization ] [ Designated as safety issue: Yes ]

Enrollment: 183
Study Start Date: April 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   46 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047566

Locations
Netherlands
Sanofi-Aventis Administrative Office
PE Gouda, Netherlands
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01047566     History of Changes
Obsolete Identifiers: NCT01117207
Other Study ID Numbers: DRONE_L_05066, 2009-018215-53
Study First Received: January 12, 2010
Last Updated: November 9, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Adrenergic beta-Antagonists
Calcium Channel Blockers
Digoxin
Amiodarone
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses
Cardiotonic Agents
Enzyme Inhibitors
Anti-Arrhythmia Agents
Protective Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013