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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232232
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : May 12, 2015
Information provided by (Responsible Party):
Melbourne Health

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Drug: Fish oil Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : September 2003
Actual Primary Completion Date : July 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Fish oil
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control
No fish oil
Experimental: Fish oil
Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio
Drug: Fish oil

Primary Outcome Measures :
  1. The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm. [ Time Frame: 18 months ]

Other Outcome Measures:
  1. Adverse events related to fish oil ingestion. [ Time Frame: 18 months ]
    Tolerability, mortality.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232232

Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Principal Investigator: Paul Sparks Melbourne Health

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Melbourne Health Identifier: NCT00232232     History of Changes
Other Study ID Numbers: 2003.074
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Keywords provided by Melbourne Health:
Atrial mechanical stunning and
atrial electrical remodeling

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes