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

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

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

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


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Ages Eligible for Study:   46 Years and older   (Adult, Senior)
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047566


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

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

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Calcium, Dietary
Adrenergic beta-Antagonists
Digoxin
Amiodarone
Calcium Channel Blockers
Bone Density Conservation Agents
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors