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.

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-01
• Results First Submitted: 2013-01-10
• Results First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Results First Posted: 2013-02-12
• Last Update Posted: 2013-02-12

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 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

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