Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232232
• Other study ID #: 2003.074
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2005
• Last updated: May 8, 2015
• Start date: September 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 oils may be of benefit to patients with certain heart rhythm disturbances called atrial fibrillation and atrial flutter.

Atrial fibrillation and atrial flutter are two heart conditions that can be successfully treated in the hospital by an ablation (in the case of atrial flutter) or a cardioversion (in the case of atrial fibrillation). Ablation involves the application of high frequency energy waves to a particular spot in the heart. Cardioversion involves resetting the heart back to a normal rhythm with the use of an electric current.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic atrial flutter requiring radiofrequency ablation.

• Chronic atrial fibrillation requiring internal cardioversion.

Exclusion Criteria:

• Sinus rhythm.

• Pregnancy.

• Patients > 80 years and < 18 years of age

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
• Atrial Flutter

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	Adverse events related to fish oil ingestion.	Tolerability, mortality.	18 months	Yes
Primary	The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.		18 months	No