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

Phase 4

Terminated

Conditions: Atrial Fibrillation

Interventions: Drug: Placebo (for Dronedarone)
Drug: Dronedarone

Registration Number: NCT01198873

Lead Sponsor: Sanofi

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (for Dronedarone)	Placebo (for Dronedarone) twice a day
Dronedarone	Dronedarone	Dronedarone 400 mg twice a day

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Left Atrial Volume Index (LAVi)	baseline (before randomization) and post-baseline (after 3-12 months of treatment)	Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.

Secondary Outcome Measures

Name	Time	Method
Changes From Baseline in Left Atrial Function	baseline (before randomization) and post-baseline (after 3-12 months of treatment)	left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.
Changes From Baseline in Left Atrial Dimension	baseline (before randomization) and post-baseline (after 3-12 months of treatment)	Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis.
Changes From Baseline in Left Ventricular Ejection Fraction (LVEF)	baseline (before randomization) and post-baseline (after 3-12 months of treatment)	Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis.
Changes From Baseline in Left Ventricular Function	baseline (before randomization) and post-baseline (after 3-12 months of treatment)	left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis.

Trial Locations

Locations (57): Investigational Site Number 840031
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Ocala, Florida, United States
Investigational Site Number 840051
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St Petersburg, Florida, United States
Investigational Site Number 840102
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St. Louis, Missouri, United States
Investigational Site Number 840004
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Troy, New York, United States
Investigational Site Number 840042
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Santa Ana, California, United States
Investigational Site Number 840028
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Camp Hill, Pennsylvania, United States
Investigational Site Number 840014
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Longview, Texas, United States
Investigational Site Number 840012
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Kalispell, Montana, United States
Investigational Site Number 840085
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Winchester, Virginia, United States
Investigational Site Number 840038
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St Louis, Missouri, United States
Investigational Site Number 840009
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Maumee, Ohio, United States
Investigational Site Number 840023
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Milwaukee, Wisconsin, United States
Investigational Site Number 840069
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Manassas, Virginia, United States
Investigational Site Number 840087
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Richmond, Virginia, United States
Investigational Site Number 840101
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Picayune, Mississippi, United States
Investigational Site Number 840078
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St Louis, Missouri, United States
Investigational Site Number 840080
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Madison, Wisconsin, United States
Investigational Site Number 840003
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Bronx, New York, United States
Investigational Site Number 840090
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Lincoln, Nebraska, United States
Investigational Site Number 840027
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Wakefield, Rhode Island, United States
Investigational Site Number 840067
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Wyomissing, Pennsylvania, United States
Investigational Site Number 840091
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Spokane, Washington, United States
Investigational Site Number 840055
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Manhasset, New York, United States
Investigational Site Number 840046
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Knoxville, Tennessee, United States
Investigational Site Number 840013
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Burien, Washington, United States
Investigational Site Number 124003
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Cambridge, Ontario, Canada
Investigational Site Number 840068
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Danville, Virginia, United States
Investigational Site Number 840072
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Phoenix, Arizona, United States
Investigational Site Number 840015
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Little Rock, Arkansas, United States
Investigational Site Number 840086
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Beverly Hills, California, United States
Investigational Site Number 840029
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Merced, California, United States
Investigational Site Number 840018
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Loma Linda, California, United States
Investigational Site Number 840044
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Redwood City, California, United States
Investigational Site Number 840057
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Stamford, Connecticut, United States
Investigational Site Number 840060
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Vista, California, United States
Investigational Site Number 840002
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Newark, Delaware, United States
Investigational Site Number 840063
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Wilmington, Delaware, United States
Investigational Site Number 840010
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Jacksonville, Florida, United States
Investigational Site Number 840071
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Jupiter, Florida, United States
Investigational Site Number 840061
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Lakeland, Florida, United States
Investigational Site Number 840096
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Lauderdale Lakes, Florida, United States
Investigational Site Number 840070
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Bradenton, Florida, United States
Investigational Site Number 840074
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Orlando, Florida, United States
Investigational Site Number 840081
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Roswell, Georgia, United States
Investigational Site Number 840016
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Ormond Beach, Florida, United States
Investigational Site Number 840106
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Peoria, Illinois, United States
Investigational Site Number 840099
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Lexington, Kentucky, United States
Investigational Site Number 840103
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Jerseyville, Illinois, United States
Investigational Site Number 840066
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Elkhart, Indiana, United States
Investigational Site Number 840039
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Owensboro, Kentucky, United States
Investigational Site Number 840040
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Auburn, Maine, United States
Investigational Site Number 840092
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Baton Rouge, Louisiana, United States
Investigational Site Number 840077
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Ayer, Massachusetts, United States
Investigational Site Number 840050
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Alpena, Michigan, United States
Investigational Site Number 840041
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Saginaw, Michigan, United States
Investigational Site Number 840058
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Minneapolis, Minnesota, United States
Investigational Site Number 840045
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Buffalo, New York, United States