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

NCT ID: NCT00232219

Last Updated: 2015-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

No fish oil exposure

Group Type NO_INTERVENTION

No interventions assigned to this group

Fish oil

Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio.

Group Type EXPERIMENTAL

Fish oil

Intervention Type DRUG

Interventions

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Fish oil

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Melbourne Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Sparks, MBBS, PhD. FRACP

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

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Royal Melbourne hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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2003.188

Identifier Type: -

Identifier Source: org_study_id

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