Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Use of Fish Oils to Reduce Recurrence of Atrial Fibrillation Following DC Cardioversion.
Secondary ID [1] 0 0
2003.188
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence of atrial fibrillation followed cardioversion
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* Patients with persistent Atrial Fibrillation on Warfarin.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Melbourne hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00232219
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sparks, MBBS, PhD. FRACP
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00232219