Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00232232




Registration number
NCT00232232
Ethics application status
Date submitted
2/10/2005
Date registered
4/10/2005
Date last updated
12/05/2015

Titles & IDs
Public title
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia
Scientific title
Secondary ID [1] 0 0
2003.074
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Atrial Flutter 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fish oil

No Intervention: Control - No fish oil

Experimental: Fish oil - Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio


Treatment: Drugs: Fish oil
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.
Timepoint [1] 0 0
18 months

Eligibility
Key inclusion criteria
- Chronic atrial flutter requiring radiofrequency ablation.

- Chronic atrial fibrillation requiring internal cardioversion.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Sinus rhythm.

- Pregnancy.

- Patients > 80 years and < 18 years of age

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
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2013
Sample size
Target
100
Accrual to date
Final
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 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 website
https://clinicaltrials.gov/ct2/show/NCT00232232
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Sparks
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