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

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.
ClinicalTrials.gov Identifier: NCT00232219
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : May 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.
Study Start Date : January 2003
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Recurrence of atrial fibrillation followed cardioversion [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Safety and tolerability [ Time Frame: 1 year ]

Eligibility Criteria

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
Criteria

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00232219


Locations
Australia, Victoria
Royal Melbourne hospital
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Paul Sparks, MBBS, PhD. FRACP Melbourne Health
More Information

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00232219     History of Changes
Other Study ID Numbers: 2003.188
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: May 5, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes