Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion

May 4, 2015 updated by: Melbourne Health

Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.

The purpose of this study is to investigate whether fish oil supplements may be beneficial in preventing the recurrence of atrial fibrillation after cardioversion.

Atrial fibrillation is a heart condition which can sometimes be successfully treated by a cardioversion.

Cardioversion involves resetting the heart back to normal with the use of electric current.

There is a tendency for the atrial fibrillation to recur , days weeks or even months after the cardioversion.

Fish oil supplements may be of benefit to patients with heart problems Recent evidence suggests that fish oils may be beneficial to patients with rhythm disturbances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

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

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with persistent Atrial Fibrillation on Warfarin.

Exclusion Criteria:

  • paroxysmal atrial fibrillation with self terminating episodes.
  • left atrial size>6.0cm
  • myocardial infarction in the previous 6 months.
  • contraindications to amiodarone use .
  • cardiac surgery in the previous 3 months .
  • an acute reversible illness contributing to the development of af
  • a QTc interval > 480ms.
  • pregnancy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No fish oil exposure
Experimental: Fish oil
Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio.
Drug: Fish oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of atrial fibrillation followed cardioversion
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

Melbourne Health

Investigators

  • Principal Investigator: Paul Sparks, MBBS, PhD. FRACP, Melbourne Health

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, 2003

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

October 2, 2005

First Submitted That Met QC Criteria

October 2, 2005

First Posted (Estimate)

October 4, 2005

Study Record Updates

Last Update Posted (Estimate)

May 5, 2015

Last Update Submitted That Met QC Criteria

May 4, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003.188

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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