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Completed

NCT Number: NCT01198275

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Brescia, 25100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

n-3 PUFAs

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

Other names: OMACOR

Placebo

Drug

1.0 g of olive oil,one capsule twice a day

RASS inhibitors and/or RAS blockers

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.

Other names: renin-angiotensin-aldosterone system inhibitor

Amiodarone

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.

Primary outcomes

  1. Probability of Maintenance of Sinus Rhythm at One-year Follow up.(Number of Patients Who Maintained Sinus Rhythm)

    Time frame: 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 outcomes

  1. The Mean Time to a First Recurrence of AF and the Rate of AF Recurrence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 10, 2010
Registry last updated
Jan 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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