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

Atrial Fibrillation Clinical Trial

Official title: 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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT01198873
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 4
• Start date: September 2010
• Completion date: January 2012