Back to resultsUse of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion
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 with persistent Atrial Fibrillation on Warfarin. Exclusion Criteria: paroxysmal atrial fibrillation with self terminating episodes. left atrial size>6.0cm myocardial infarction in the previous 6 months. contraindications to amiodarone use . cardiac surgery in the previous 3 months . an acute reversible illness contributing to the development of af a QTc interval > 480ms. pregnancy
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 exposure
Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio.
Outcomes
Primary Outcome Measures
Recurrence of atrial fibrillation followed cardioversion
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232219
Brief Title
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion
Official Title
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
November 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 oil supplements may be beneficial in preventing the recurrence of atrial fibrillation after cardioversion.
Atrial fibrillation is a heart condition which can sometimes be successfully treated by a cardioversion.
Cardioversion involves resetting the heart back to normal with the use of electric current.
There is a tendency for the atrial fibrillation to recur , days weeks or even months after the cardioversion.
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.
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
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
No fish oil exposure
Arm Title
Fish oil
Arm Type
Experimental
Arm Description
Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio.
Intervention Type
Drug
Intervention Name(s)
Fish oil
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation followed cardioversion
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Safety and tolerability
Time Frame
1 year
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:
Patients with persistent Atrial Fibrillation on Warfarin.
Exclusion Criteria:
paroxysmal atrial fibrillation with self terminating episodes.
left atrial size>6.0cm
myocardial infarction in the previous 6 months.
contraindications to amiodarone use .
cardiac surgery in the previous 3 months .
an acute reversible illness contributing to the development of af
a QTc interval > 480ms.
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sparks, MBBS, PhD. FRACP
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
Learn more about this trial
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion
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