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



Status:Archived
Conditions:Atrial Fibrillation, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010
End Date:June 2012

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A Placebo-Controlled, Double-Blind, Randomized, Multi-center Study to Assess the Effects of Dronedarone 400 mg BID on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement


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


The total study period per subject is 12.5 months broken down as follows:

- Treatment period: 12 months

- Follow-up period: 2 weeks


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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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1250 E. Marshall St.
Richmond, Virginia 23298
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