Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000341325
Ethics application status
Approved
Date submitted
23/06/2008
Date registered
18/07/2008
Date last updated
17/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of dietary administration of n-3 polyunsaturated fatty acids on cardiac electrophysiology in humans
Scientific title
Effects of dietary administration of n-3 polyunsaturated fatty acids on cardiac electrophysiology in humans undergoing cardiac electrophysiology testing and/or ablation for supraventricular tachycardia
Secondary ID [1] 603 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
supraventricular tachycardia 3299 0
Condition category
Condition code
Cardiovascular 3461 3461 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
liquid fish oil containing 18% eicosapentaenoic acid (EPA) + 12% docosahexaenoic acid (DHA). 15 ml/day for 21 days days prior to electrophysiology study/ablation
Intervention code [1] 3038 0
Other interventions
Comparator / control treatment
liquid sunola oil (high oleic acid sunflower oil). 15 ml/day for 21 days immediately prior to electrophysiology study/ablation
Control group
Placebo

Outcomes
Primary outcome [1] 4359 0
Atrial refractory periods at a) high lateral right atrium b) low lateral right atrium c) proximal coronary sinus d) distal coronary sinus e) High atrial septum
Timepoint [1] 4359 0
at time of electrophysiology study/ablation ie at day 21
Primary outcome [2] 4360 0
Conduction velocity: a) Total conduction time (lateral right atrium to distal coronary sinus), b) Coronary sinus, c) Lateral right atrium
Timepoint [2] 4360 0
at time of electrophysiology study/ablation ie at day 21
Primary outcome [3] 4361 0
corrected sinus node recovery time
Timepoint [3] 4361 0
at time of electrophysiology study/ablation ie at day 21
Secondary outcome [1] 7345 0
Wenckebach cycle length of the atrio-ventricular node
Timepoint [1] 7345 0
at time of electrophysiology study/ablation ie at day 21

Eligibility
Key inclusion criteria
undergoing an elective cardiac electrophysiology procedure (electrophysiology study +/- ablation for supraventricular tachycardia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Cardiac rhythm other than sinus rhythm at the time of the procedure
b) Current use of fish oil supplements
c) Known impaired lipid metabolism
d) Uncontrolled diabetes mellitus
e) Known allergy to fish
f) Current use of anti-arrhythmics other than ß-blockers, or use of amiodarone within the past 3 months
g) New York Heart Association Grade II-IV heart failure
h) Known bleeding disorder

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject enrolled during consultation with physician, who will telephone trial manager for next subject number and group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
http://www.random.org/integers
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3507 0
Charities/Societies/Foundations
Name [1] 3507 0
National Heart Foundation of Australia
Country [1] 3507 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
North Tce
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 3149 0
None
Name [1] 3149 0
Address [1] 3149 0
Country [1] 3149 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5544 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 5544 0
North Tce
Adelaide SA 5000
Ethics committee country [1] 5544 0
Australia
Date submitted for ethics approval [1] 5544 0
Approval date [1] 5544 0
Ethics approval number [1] 5544 0

Summary
Brief summary
In this study, we will examine the effects of n-3 fatty acids on the electrophysiology of the heart in a bid to determine possible mechanisms for anti-arrhythmic effects of n-3 fatty acids
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28693 0
Address 28693 0
Country 28693 0
Phone 28693 0
Fax 28693 0
Email 28693 0
Contact person for public queries
Name 11850 0
Robert Metcalf
Address 11850 0
Level4 Eleanor Harrald Bldg
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 11850 0
Australia
Phone 11850 0
08 82225581
Fax 11850 0
08 82225895
Email 11850 0
[email protected]
Contact person for scientific queries
Name 2778 0
Robert Metcalf
Address 2778 0
level4 Eleanor Harrald Bldg
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 2778 0
Australia
Phone 2778 0
61 8 82225581
Fax 2778 0
61 8 82225895
Email 2778 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.