Use of Fish Oils to Prevent Atrial Mechanical Stunning an... | NCT00232232

Studies
Use of Fish Oils to Prevent Atrial Mechanical Stunning and Atrial Remodeling Due to Atrial Arrhythmia

NCT00232232

Sponsor

Melbourne Health

Status

Completed

Last Update Posted

May 12, 2015Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Atrial Fibrillation
Atrial Flutter

Interventions

Fish oil

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2003

Primary Completion Date

Jul 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 2, 2005

First Submission Date that Met QC Criteria

Oct 2, 2005

First Posted Date

Oct 4, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2015

Last Update Posted Date

May 12, 2015Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	No fish oil
Fish oil	Experimental	Patients prescribed 6g/day of fish oil containing 1.8g EPA+DHA in a 1.5:1 ratio	Drug: Fish oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fish oil	Drug		Fish oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The extent of left atrial stunning in fish oil group compared to control after reversion of atrial arrhythmias to sinus rhythm.		18 months

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Adverse events related to fish oil ingestion.	Tolerability, mortality.	18 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Sparks	Melbourne Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Melbourne Hospital		Melbourne	Victoria	3050	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21232631	Derived	Kumar S, Sutherland F, Wheeler M, Heck PM, Lee G, Teh AW, Garg ML, Morgan JG, Sparks PB. Effects of chronic omega-3 polyunsaturated fatty acid supplementation on human atrial mechanical function after reversion of atrial arrhythmias to sinus rhythm: reversal of tachycardia-mediated atrial cardiomyopathy with fish oils. Heart Rhythm. 2011 May;8(5):643-9. doi: 10.1016/j.hrthm.2011.01.014. Epub 2011 Jan 11.

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D009821	Oils
D008055	Lipids

ID	Term
D001281	Atrial Fibrillation
D001282	Atrial Flutter