Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 atrial-fibrillation
Started Sep 2003
Longer than P75 for phase_4 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
October 2, 2005
CompletedFirst Posted
Study publicly available on registry
October 4, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 12, 2015
May 1, 2015
9.8 years
October 2, 2005
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.
18 months
Other Outcomes (1)
Adverse events related to fish oil ingestion.
18 months
Study Arms (2)
Control
NO INTERVENTIONNo fish oil
Fish oil
EXPERIMENTALPatients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio
Interventions
Eligibility Criteria
You may qualify if:
- Chronic atrial flutter requiring radiofrequency ablation.
- Chronic atrial fibrillation requiring internal cardioversion.
You may not qualify if:
- Sinus rhythm.
- Pregnancy.
- Patients \> 80 years and \< 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Melbourne Healthlead
Study Sites (1)
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
Related Publications (1)
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.
PMID: 21232631DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Sparks
Melbourne Health
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2005
First Posted
October 4, 2005
Study Start
September 1, 2003
Primary Completion
July 1, 2013
Study Completion
November 1, 2013
Last Updated
May 12, 2015
Record last verified: 2015-05