Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement

NCT ID: NCT01198873

Last Updated: 2013-02-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-01-31

Brief Summary

Primary Objective:

• Evaluate the effect of dronedarone versus placebo (standard therapy) in slowing the progression of adverse left atrial remodeling in patients with atrial fibrillation (AF) following 12 months of treatment.

Secondary Objectives:

• Evaluate the effects of dronedarone versus placebo on left atrial function;
• Evaluate the effects of dronedarone versus placebo on left atrial dimension;
• Evaluate the effects of dronedarone versus placebo on left ventricular function (LVEF, E, E', A, E/E')
• Evaluate the safety and tolerability of dronedarone.

Detailed Description

The planned total study period per participant was 12 months and 3 weeks broken down as follows:

• Screening period: up to 1 week;
• Treatment period: 12 months;
• Follow-up period: 2 weeks.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dronedarone

Dronedarone 400 mg twice a day

Group Type: EXPERIMENTAL

Dronedarone

Intervention Type: DRUG

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Placebo

Placebo (for Dronedarone) twice a day

Group Type: PLACEBO_COMPARATOR

Placebo (for Dronedarone)

Intervention Type: DRUG

film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Interventions

Dronedarone

Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner)

Intervention Type: DRUG

Placebo (for Dronedarone)

film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Intervention Type: DRUG

Other Intervention Names

Multaq®; SR33589

Eligibility Criteria

Inclusion Criteria

• Signed written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization;
• Nonpermanent AF or AF/Atrial Flutter (AFL) documented electrocardiographically by both AF (or AF/AFL) and sinus rhythm within the prior 12 months;
• At screening, sinus rhythm and Left Atrial Volume index (LAVi) ≥32 mL/m2 based on 2D-echocardiography;
• At least one of the following cardiovascular (CV) risk factors: Age >70 years at start of screening, hypertension, diabetes mellitus, prior CV accident (stroke or transient ischemic attack) or systemic embolism, or left ventricular ejection fraction <0.40.

Exclusion Criteria

• Permanent AF defined as continuous AF for 6 months or longer;
• Persistent AF defined as sustained AF >7 days duration and/or requiring cardioversion in the 4 weeks before screening;
• Prior valvular heart surgery or significant valvular heart disease including rheumatic heart disease or acquired valvular heart disease;
• Aortic or mitral regurgitation greater than mild (>1+) or any degree of mitral stenosis at the screening echocardiogram;
• Myocardial infarction within the 6 months prior to screening or stroke within 2 months prior to screening;
• Pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy devices placed within the 6 months prior to screening or at anytime during the study;
• Ongoing potentially dangerous symptoms when in AF/AFL such as angina pectoris, transient ischemic attacks, stroke, syncope as judged by the Investigator;
• Cardiac ablative procedure or cardiac surgery within 3 months prior to screening, or percutaneous coronary intervention within 4 weeks prior to screening;
• Need for concomitant medication that is prohibited in this trial, and would preclude the use of the study drug during the planned study period including the following:

• Antiarrhythmics (eg, amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol);
• Drugs or products that are strong inhibitors of CYP3A (eg, ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir, and grapefruit juice);
• Drugs that are inducers of CYP3A (eg, rifampin, phenobarbital, carbamazepine, phenytoin, and St John's wort);
• QTc Bazett interval ≥500 msec on the screening ECG;
• Bradycardia <50 bpm and/or PR interval ≥0.28 sec on the screening ECG unless the patient has a functional pacemaker;
• New York Heart Association (NYHA) Class IV heart failure or NYHA Class II or III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic within 4 weeks prior to screening.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840072

Phoenix, Arizona, United States

Investigational Site Number 840015

Little Rock, Arkansas, United States

Investigational Site Number 840086

Beverly Hills, California, United States

Investigational Site Number 840018

Loma Linda, California, United States

Investigational Site Number 840029

Merced, California, United States

Investigational Site Number 840044

Redwood City, California, United States

Investigational Site Number 840042

Santa Ana, California, United States

Investigational Site Number 840060

Vista, California, United States

Investigational Site Number 840057

Stamford, Connecticut, United States

Investigational Site Number 840002

Newark, Delaware, United States

Investigational Site Number 840063

Wilmington, Delaware, United States

Investigational Site Number 840070

Bradenton, Florida, United States

Investigational Site Number 840010

Jacksonville, Florida, United States

Investigational Site Number 840071

Jupiter, Florida, United States

Investigational Site Number 840061

Lakeland, Florida, United States

Investigational Site Number 840096

Lauderdale Lakes, Florida, United States

Investigational Site Number 840031

Ocala, Florida, United States

Investigational Site Number 840074

Orlando, Florida, United States

Investigational Site Number 840016

Ormond Beach, Florida, United States

Investigational Site Number 840051

St. Petersburg, Florida, United States

Investigational Site Number 840081

Roswell, Georgia, United States

Investigational Site Number 840103

Jerseyville, Illinois, United States

Investigational Site Number 840106

Peoria, Illinois, United States

Investigational Site Number 840066

Elkhart, Indiana, United States

Investigational Site Number 840099

Lexington, Kentucky, United States

Investigational Site Number 840039

Owensboro, Kentucky, United States

Investigational Site Number 840092

Baton Rouge, Louisiana, United States

Investigational Site Number 840040

Auburn, Maine, United States

Investigational Site Number 840077

Ayer, Massachusetts, United States

Investigational Site Number 840050

Alpena, Michigan, United States

Investigational Site Number 840041

Saginaw, Michigan, United States

Investigational Site Number 840058

Minneapolis, Minnesota, United States

Investigational Site Number 840101

Picayune, Mississippi, United States

Investigational Site Number 840078

St Louis, Missouri, United States

Investigational Site Number 840038

St Louis, Missouri, United States

Investigational Site Number 840102

St Louis, Missouri, United States

Investigational Site Number 840012

Kalispell, Montana, United States

Investigational Site Number 840090

Lincoln, Nebraska, United States

Investigational Site Number 840045

Buffalo, New York, United States

Investigational Site Number 840055

Manhasset, New York, United States

Investigational Site Number 840003

The Bronx, New York, United States

Investigational Site Number 840004

Troy, New York, United States

Investigational Site Number 840009

Maumee, Ohio, United States

Investigational Site Number 840028

Camp Hill, Pennsylvania, United States

Investigational Site Number 840067

Wyomissing, Pennsylvania, United States

Investigational Site Number 840027

Wakefield, Rhode Island, United States

Investigational Site Number 840046

Knoxville, Tennessee, United States

Investigational Site Number 840014

Longview, Texas, United States

Investigational Site Number 840068

Danville, Virginia, United States

Investigational Site Number 840069

Manassas, Virginia, United States

Investigational Site Number 840087

Richmond, Virginia, United States

Investigational Site Number 840085

Winchester, Virginia, United States

Investigational Site Number 840013

Burien, Washington, United States

Investigational Site Number 840091

Spokane, Washington, United States

Investigational Site Number 840080

Madison, Wisconsin, United States

Investigational Site Number 840023

Milwaukee, Wisconsin, United States

Investigational Site Number 124003

Cambridge, Ontario, Canada

Countries

United States; Canada

Other Identifiers

DRONE_L_04315

Identifier Type: -

Identifier Source: org_study_id