n-3 Polyunsaturated Fatty Acids (PUFAs) in the Prevention of Atrial Fibrillation

Phase 3

Completed

Interventions: Drug: n-3 PUFAs
Drug: Placebo
Drug: RASS inhibitors and/or RAS blockers
Drug: Amiodarone

Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Brief Summary: The purpose of this study is to determine the effect of n-3 PUFAs in addition to amiodarone and renin-angiotensin-aldosterone system (RAAS) inhibitors on the maintenance of sinus rhythm after electrical conversion in patients with persistent Atrial fibrillation (AF).

Detailed Description: Atrial fibrillation (AF) is the most common sustained arrhythmia and represents an increasing burden on the healthcare system. Treatment of AF remains controversial. In patients on antiarrhythmic therapy, the one-year relapse rates of AF after cardioversion ranges from 44% to 77% at one year and amiodarone appears to the be the most effective in maintaining sinus rhythm.Over the last few years, a growing amount of evidences has supported the protective effects of n-3 PUFAs in preventing ventricular arrhythmias and reducing the risk of sudden cardiac death. Furthermore, in the last years, the interest for their possible beneficial role in AF prevention has been increasing.We hypothesized that the administration of n-3 PUFAs could reduce the AF recurrence rate more than amiodarone plus RAAS inhibitors in patients with persistent AF. Therefore the present study aims to evaluate the role of n-3 PUFAs in the prophylaxis of AF recurrences after DCCV in addition to amiodarone and RAS blockers therapy in patients with persistent AF.

Recruitment & Eligibility

Inclusion Criteria

persistent Atrial Fibrillation (AF) lasting > one month
history of at least one AF relapse after previous electrical or Pharmacological cardioversion

Exclusion Criteria

left atrium size > 6 cm
severe valvulopathy
myocardial infarction during the previous 6 months
unstable angina
NYHA heart failure class IV or hemodynamic instability
cardiac surgery during the previous 3 months
significant pulmonary thyroid and hepatic disease
contraindications to treatment with amiodarone or RASS inhibitors
chronic renal dysfunction
QT > 480 msec in the absence of bundle-branch block
bradycardia < 50 b/min
diagnosis of paroxysmal AF
hyperkalemia
pregnancy
any disease or other medical treatment that, in the opinion of the investigators, could interfere with the study.

Arm && Interventions

Group	Intervention	Description
n-3 PUFAs	n-3 PUFAs	-
n-3 PUFAs	RASS inhibitors and/or RAS blockers	-
n-3 PUFAs	Amiodarone	-
placebo	Placebo	-
placebo	RASS inhibitors and/or RAS blockers	-
placebo	Amiodarone	-

Primary Outcome Measures

Name	Time	Method
Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)	one year	Sinus Rhythm maintenance means no Atrial Fibrillation recurrence at one-year follow up. Patients with successful electrical cardioversion (DCCV)underwent weekly clinical and electrocardiographic controls for the first three weeks following cardioversion. Subsequently, follow up visits with performance of clinical evaluation, ECG, and a 24-hour Holter monitoring were performed at 1, 3, 6 and 12 months after DCCV.

Secondary Outcome Measures

Name	Time	Method
The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence	1, 3 and 6 months	The mean time to a first recurrence of AF; and the rate of AF recurrence at 1, 3 and 6 months.