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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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n-3 PUFAs

Group Type ACTIVE_COMPARATOR

n-3 PUFAs

Intervention Type DRUG

1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day

RASS inhibitors and/or RAS blockers

Intervention Type DRUG

Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.

Amiodarone

Intervention Type DRUG

Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1.0 g of olive oil,one capsule twice a day

RASS inhibitors and/or RAS blockers

Intervention Type DRUG

Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.

Amiodarone

Intervention Type DRUG

Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

Interventions

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n-3 PUFAs

1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day

Intervention Type DRUG

Placebo

1.0 g of olive oil,one capsule twice a day

Intervention Type DRUG

RASS inhibitors and/or RAS blockers

Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.

Intervention Type DRUG

Amiodarone

Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.

Intervention Type DRUG

Other Intervention Names

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OMACOR renin-angiotensin-aldosterone system inhibitor

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Savina Nodari

N-3 Polyunsaturated Fatty Acids (n-3 PUFAs) in the Prevention of Atrial Fibrillation Recurrences After Electrical Cardioversion. A Prospective Randomized Study.

Responsibility Role PRINCIPAL_INVESTIGATOR