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

November 9, 2011 updated by: Sanofi

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • PE Gouda, Netherlands
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ventricular rate
Time Frame: One week
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular rate
Time Frame: 12 weeks
12 weeks
Patients with registered AF episodes
Time Frame: Within the 12 weeks after randomization
Within the 12 weeks after randomization
Patients with symptomatic AF episodes
Time Frame: Within the 12 weeks after randomization
Within the 12 weeks after randomization
Severity of AF and AF-like symptoms
Time Frame: Within the 12 weeks after randomization
Within the 12 weeks after randomization
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)
Within the 12 weeks after randomization
Patients with symptomatic episodes of bradycardia
Time Frame: Within the 12 weeks after randomization
Within the 12 weeks after randomization
Patients with low heart rate (<60 bpm)
Time Frame: Within the 12 weeks after randomization
Within the 12 weeks after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (ESTIMATE)

January 13, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 10, 2011

Last Update Submitted That Met QC Criteria

November 9, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRONE_L_05066
  • 2009-018215-53 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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