Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 76
Healthy volunteers: no

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.

Arms:
arm 1: Dronedarone 400 mg twice a day arm 2: Placebo (for Dronedarone) twice a day

Interventions: intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner) intervention 2: film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Protocol document: