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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Phase 4

Locations

Netherlands

Study Type

Interventional

Intervention

Dronedarone

Beta blocker or calcium antagonist or digoxin

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

46 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Addition of dronedarone

Dose Increase

Arm Description

Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)

Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)

Outcomes

Primary Outcome Measures

Ventricular rate

Secondary Outcome Measures

Ventricular rate

Patients with registered AF episodes

Patients with symptomatic AF episodes

Severity of AF and AF-like symptoms

Premature study discontinuation

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

Patients with low heart rate (<60 bpm)

Full Information

NCT ID

NCT01047566

First Posted

January 12, 2010

Last Updated

November 9, 2011

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01047566

Brief Title

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

Acronym

AFRODITE

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 Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

183 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Addition of dronedarone

Arm Type

Experimental

Arm Description

Addition of Dronedarone to existing rate control medication (beta blocker and/or calcium antagonist)

Arm Title

Dose Increase

Arm Type

Active Comparator

Arm Description

Dose increase of existing rate control medication (beta blocker or calcium antagonist or digoxin)

Intervention Type

Drug

Intervention Name(s)

Dronedarone

Other Intervention Name(s)

Multaq

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Beta blocker or calcium antagonist or digoxin

Intervention Description

Dose increase of beta blocker or calcium antagonist or digoxin

Primary Outcome Measure Information:

Title

Ventricular rate

Time Frame

One week

Secondary Outcome Measure Information:

Title

Ventricular rate

Time Frame

12 weeks

Title

Patients with registered AF episodes

Time Frame