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

January 19, 2012 updated by: Savina Nodari, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25100
        • Arrhytmias and Heart failure Unit-Spedali Civili Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
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.
Other Names:
  • renin-angiotensin-aldosterone system inhibitor
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.
Drug: Placebo
1.0 g of olive oil,one capsule twice a day
Active Comparator: n-3 PUFAs
Drug: 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
Other Names:
  • OMACOR
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.
Other Names:
  • renin-angiotensin-aldosterone system inhibitor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-PUFA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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