Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.

May 28, 2013 updated by: Melbourne Health

The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

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.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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

    • 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 88 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.

Exclusion Criteria:

  • Patients with chronic atrial fibrillation

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fish oil
Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
NO_INTERVENTION: Control
No fish oil exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial tachycardia and atrial fibrillation burden
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency and duration of atrial tachycardia/fibrillation episodes
Time Frame: 18 months
18 months

Other Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of fish oil
Time Frame: 18 months
18 months

Collaborators and Investigators

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

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.

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

December 1, 2003

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 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 30, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2003.216

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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