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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Melbourne Health.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232232
First received: October 2, 2005
Last updated: May 28, 2013
Last verified: July 2011
  Purpose

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 Intervention Phase
Atrial Fibrillation
Atrial Flutter
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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Adverse events related to fish oil ingestion. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Tolerability, mortality.


Estimated Enrollment: 100
Study Start Date: September 2003
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00232232

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

No publications provided by Melbourne Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00232232     History of Changes
Other Study ID Numbers: 2003.074
Study First Received: October 2, 2005
Last Updated: May 28, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014