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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232219
First received: October 2, 2005
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Atrial Fibrillation
Drug: Fish oil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Recurrence of atrial fibrillation followed cardioversion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2003
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00232219     History of Changes
Other Study ID Numbers: 2003.188
Study First Received: October 2, 2005
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

ClinicalTrials.gov processed this record on November 20, 2014