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

NCT01047566 | Completed Phase 4

• 2 other identifiers: DRONE_L_050662009-018215-53
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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)

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Ventricular rate

  One week

Secondary Outcomes (7)

• Ventricular rate

  12 weeks

• Patients with registered AF episodes

  Within the 12 weeks after randomization

• Patients with symptomatic AF episodes

  Within the 12 weeks after randomization

• Severity of AF and AF-like symptoms

  Within the 12 weeks after randomization

• Premature study discontinuation

  Within the 12 weeks after randomization

Study Arms (2)

Addition of dronedarone

EXPERIMENTAL

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

Drug: Dronedarone

Dose Increase

ACTIVE COMPARATOR

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

Drug: Beta blocker or calcium antagonist or digoxin

Interventions

Dronedarone DRUG

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

Also known as: Multaq

Addition of dronedarone

Beta blocker or calcium antagonist or digoxin DRUG

Dose increase of beta blocker or calcium antagonist or digoxin

Dose Increase

Eligibility Criteria

• Age: 46 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

PE Gouda, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dronedarone; Adrenergic beta-Antagonists; Calcium Channel Blockers; Digoxin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amiodarone; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Cardiovascular Agents; Therapeutic Uses; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 10, 2011

Record last verified: 2011-11

Locations

NL (1)