Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232245
First received: October 2, 2005
Last updated: May 28, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.

Atrial fibrillation is a heart condition which effects a large percentage of the population .

Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .

Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.

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.

By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.


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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • Atrial tachycardia and atrial fibrillation burden [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and duration of atrial tachycardia/fibrillation episodes [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety and tolerability of fish oil [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: December 2003
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish oil
Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
Drug: Fish oil
No Intervention: Control
No fish oil exposure

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.

Exclusion Criteria:

  • Patients with chronic atrial fibrillation
  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: NCT00232245

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: NCT00232245     History of Changes
Other Study ID Numbers: 2003.216
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
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014