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Completed

NCT Number: NCT01047566

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

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)

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

46 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office

PE Gouda, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DRONEDARONE

Drug

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

Other names: Multaq

Beta blocker or calcium antagonist or digoxin

Drug

Dose increase of beta blocker or calcium antagonist or digoxin

Primary outcomes

  1. Ventricular rate

    Time frame: One week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: AFRODITE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 13, 2010
Registry last updated
Nov 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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