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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047566
• Other study ID #: DRONE_L_05066
• Secondary ID: 2009-018215-53
• Status: Completed
• Phase: Phase 4
• First received: January 12, 2010
• Last updated: November 9, 2011
• Start date: April 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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)

Other known NCT identifiers

• NCT01117207

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 46 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Dronedarone
Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg twice daily for 12 weeks (+/- 5 days)
• Beta blocker or calcium antagonist or digoxin
Dose increase of beta blocker or calcium antagonist or digoxin

Locations

Country	Name	City	State
Netherlands	Sanofi-Aventis Administrative Office	PE Gouda

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular rate		One week	No
Secondary	Ventricular rate		12 weeks	No
Secondary	Patients with registered AF episodes		Within the 12 weeks after randomization	No
Secondary	Patients with symptomatic AF episodes		Within the 12 weeks after randomization	No
Secondary	Severity of AF and AF-like symptoms		Within the 12 weeks after randomization	No
Secondary	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)	Within the 12 weeks after randomization	No
Secondary	Patients with symptomatic episodes of bradycardia		Within the 12 weeks after randomization	Yes
Secondary	Patients with low heart rate (<60 bpm)		Within the 12 weeks after randomization	Yes