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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00232219
Registration number
NCT00232219
Ethics application status
Date submitted
2/10/2005
Date registered
4/10/2005
Date last updated
5/05/2015
Titles & IDs
Public title
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion
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Scientific title
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.
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Secondary ID [1]
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2003.188
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Other
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Fish oil
No Intervention: Control - No fish oil exposure
Experimental: Fish oil - Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio.
Treatment: Drugs: Fish oil
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Recurrence of atrial fibrillation followed cardioversion
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Assessment method [1]
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Timepoint [1]
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1 year
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Eligibility
Key inclusion criteria
- Patients with persistent Atrial Fibrillation on Warfarin.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2013
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Royal Melbourne hospital - Melbourne
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Recruitment postcode(s) [1]
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3050 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melbourne Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00232219
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Sparks, MBBS, PhD. FRACP
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Address
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Melbourne Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00232219
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