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

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: Atrial Fibrillation
• Intervention / Treatment: Drug: Fish oil

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	1 year

Other Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability	1 year

Collaborators and Investigators

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

Study record dates

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: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 2003.188