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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232219
• Other study ID #: 2003.188
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2005
• Last updated: May 4, 2015
• Start date: January 2003
• Est. completion date: November 2013

Study information

• Verified date: May 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Fish oil

Locations

Country	Name	City	State
Australia	Royal Melbourne hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability		1 year	Yes
Primary	Recurrence of atrial fibrillation followed cardioversion		1 year	No