Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
Primary Purpose
Atrial Fibrillation, Atrial Flutter
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 focused on measuring Atrial mechanical stunning and, atrial electrical remodeling
Eligibility 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
Sites / Locations
- Royal Melbourne Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Fish oil
Arm Description
No fish oil
Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio
Outcomes
Primary Outcome Measures
The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232232
Brief Title
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Melbourne Health
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter
Keywords
Atrial mechanical stunning and, atrial electrical remodeling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No fish oil
Arm Title
Fish oil
Arm Type
Experimental
Arm Description
Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio
Intervention Type
Drug
Intervention Name(s)
Fish oil
Primary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Adverse events related to fish oil ingestion.
Description
Tolerability, mortality.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
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
21232631
Citation
Kumar S, Sutherland F, Wheeler M, Heck PM, Lee G, Teh AW, Garg ML, Morgan JG, Sparks PB. Effects of chronic omega-3 polyunsaturated fatty acid supplementation on human atrial mechanical function after reversion of atrial arrhythmias to sinus rhythm: reversal of tachycardia-mediated atrial cardiomyopathy with fish oils. Heart Rhythm. 2011 May;8(5):643-9. doi: 10.1016/j.hrthm.2011.01.014. Epub 2011 Jan 11.
Results Reference
derived
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Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
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