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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00232232
Other study ID # 2003.074
Secondary ID
Status Completed
Phase Phase 4
First received October 2, 2005
Last updated May 8, 2015
Start date September 2003
Est. completion date November 2013

Study information

Verified date May 2015
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority Australia: Department of Health and Ageing Therapeutic Goods Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 2013
Est. primary completion date July 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Fish oil


Locations

Country Name City State
Australia Royal Melbourne Hospital Melbourne Victoria

Sponsors (1)

Lead Sponsor Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Other Adverse events related to fish oil ingestion. Tolerability, mortality. 18 months Yes
Primary The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm. 18 months No
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