Back to resultsUse of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Fish oil
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility 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
Sites / Locations
- Royal Melbourne hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fish oil
Control
Arm Description
Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
No fish oil exposure
Outcomes
Primary Outcome Measures
Atrial tachycardia and atrial fibrillation burden
Secondary Outcome Measures
Frequency and duration of atrial tachycardia/fibrillation episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232245
Brief Title
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fish oil
Arm Type
Experimental
Arm Description
Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
Arm Title
Control
Arm Type
No Intervention
Arm Description
No fish oil exposure
Intervention Type
Drug
Intervention Name(s)
Fish oil
Primary Outcome Measure Information:
Title
Atrial tachycardia and atrial fibrillation burden
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Frequency and duration of atrial tachycardia/fibrillation episodes
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Safety and tolerability of fish oil
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
88 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sparks
Organizational Affiliation
Melbourne Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Melbourne hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
23890856
Citation
Kumar S, Sutherland F, Stevenson I, Lee JM, Garg ML, Sparks PB. Effects of long-term omega-3 polyunsaturated fatty acid supplementation on paroxysmal atrial tachyarrhythmia burden in patients with implanted pacemakers: results from a prospective randomised study. Int J Cardiol. 2013 Oct 9;168(4):3812-7. doi: 10.1016/j.ijcard.2013.06.030. Epub 2013 Jul 26.
Results Reference
derived
Learn more about this trial
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
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