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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
Melbourne Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial mechanical stunning and, atrial electrical remodeling

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 2, 2005
Last Updated
May 8, 2015
Sponsor
Melbourne Health
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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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