- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232245
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
The purpose of this study is to investigate whether fish oil supplements may reduce the frequency and duration of paroxysmal atrial fibrillation episodes.
Atrial fibrillation is a heart condition which effects a large percentage of the population .
Atrial fibrillation is a condition frequently experienced by people who have had pacemakers inserted .
Certain Pacemakers have sophisticated monitoring features that are able to recognise episodes of atrial fibrillation.
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.
By interrogating pacemakers this study will investigate the effect of fish oil supplements on the frequency and duration of episodes of atrial fibrillation.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3050
- Royal Melbourne Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who have had at least 2 previous episodes of atrial fibrillation and an implanted pacemaker.
Exclusion Criteria:
- Patients with chronic atrial fibrillation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fish oil
Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
|
|
NO_INTERVENTION: Control
No fish oil exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Atrial tachycardia and atrial fibrillation burden
Time Frame: 18 months
|
18 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency and duration of atrial tachycardia/fibrillation episodes
Time Frame: 18 months
|
18 months
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of fish oil
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003.216
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Clinical Trials on Atrial Fibrillation
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Adagio MedicalRecruitingAtrial Fibrillation | Atrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationNetherlands, Germany, Belgium
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-
R-PharmFSBI "National Medical Research Center of Cardiology named after academician...CompletedAtrial Flutter | Paroxysmal Atrial Fibrillation | Persistent Atrial FibrillationRussian Federation
Clinical Trials on Fish oil
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University of CopenhagenAnjo A/SCompletedObesity | Cardiovascular Disease | Metabolic Syndrome | Growth | Blood Pressure
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National Science Council, TaiwanCompletedMajor Depressive DisorderTaiwan
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Tufts UniversityPrevention PharmaceuticalsTerminated
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Liverpool John Moores UniversityCompleted
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Stanford UniversityNordic NaturalsCompleted
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National Heart, Lung, and Blood Institute (NHLBI)CompletedProteomics | Lipoprotein Metabolism | PCSK9United States
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National Heart, Lung, and Blood Institute (NHLBI)UnknownMyocardial Tissue in Heart Transplantation
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Melbourne HealthCompletedAtrial Fibrillation | Atrial FlutterAustralia