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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01198275

CS-PUFA-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 199 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

199 participants in 2 patient groups, including a placebo group

n-3 PUFAs

Active Comparator group

Treatment:

Drug: RASS inhibitors and/or RAS blockers

Drug: n-3 PUFAs

Drug: Amiodarone

placebo

Placebo Comparator group

Treatment:

Drug: RASS inhibitors and/or RAS blockers

Drug: Placebo

Drug: Amiodarone