drugset / Trial / NCT01198873

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

NCT01198873

Phase 4 Terminated 76 enrolled Sanofi
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2010-09
Primary completion
2012-01
Completion
2012-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dronedarone Small molecule 400 mg Oral

Indications