Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00232245
First received: October 2, 2005
Last updated: May 28, 2013
Last verified: February 2013

October 2, 2005
May 28, 2013
December 2003
January 2013   (final data collection date for primary outcome measure)
Atrial tachycardia and atrial fibrillation burden [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00232245 on ClinicalTrials.gov Archive Site
Frequency and duration of atrial tachycardia/fibrillation episodes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Safety and tolerability of fish oil [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Not Provided
 
Use of Fish Oils to Reduce the Frequency and Duration of Episodes of Atrial Fibrillation in Patients With Paroxysmal Atrial Fibrillation.
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atrial Fibrillation
Drug: Fish oil
  • Experimental: Fish oil
    Patients prescribed 6g/day of fish oil containing total 1.8 g of EPA+DHA in a 1.5:1 ratio
    Intervention: Drug: Fish oil
  • No Intervention: Control
    No fish oil exposure
Kumar S, Sutherland F, Stevenson I, Lee JM, Garg ML, Sparks PB. Effects of long-term omega-3 polyunsaturated fatty acid supplementation on paroxysmal atrial tachyarrhythmia burden in patients with implanted pacemakers: results from a prospective randomised study. Int J Cardiol. 2013 Oct 9;168(4):3812-7. doi: 10.1016/j.ijcard.2013.06.030. Epub 2013 Jul 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 88 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00232245
2003.216
Yes
Melbourne Health
Melbourne Health
Not Provided
Principal Investigator: Paul Sparks Melbourne Health
Melbourne Health
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP