NCT00232219

Brief Summary

The purpose of this study is to investigate whether fish oil supplements may be beneficial in preventing the recurrence of atrial fibrillation after cardioversion. Atrial fibrillation is a heart condition which can sometimes be successfully treated by a cardioversion. Cardioversion involves resetting the heart back to normal with the use of electric current. There is a tendency for the atrial fibrillation to recur , days weeks or even months after the cardioversion. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2003

Longer than P75 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

10.8 years

First QC Date

October 2, 2005

Last Update Submit

May 4, 2015

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial fibrillation followed cardioversion

    1 year

Other Outcomes (1)

  • Safety and tolerability

    1 year

Study Arms (2)

Control

NO INTERVENTION

No fish oil exposure

Fish oil

EXPERIMENTAL

Patients given 6g/day of fish oil containing 1.8g/d of EPA+DHA in a 1.5:1 ratio.

Drug: Fish oil

Interventions

Fish oilDRUG
Fish oil

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with persistent Atrial Fibrillation on Warfarin.

You may not qualify if:

  • paroxysmal atrial fibrillation with self terminating episodes.
  • left atrial size\>6.0cm
  • myocardial infarction in the previous 6 months.
  • contraindications to amiodarone use .
  • cardiac surgery in the previous 3 months .
  • an acute reversible illness contributing to the development of af
  • a QTc interval \> 480ms.
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Melbourne hospital

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Paul Sparks, MBBS, PhD. FRACP

    Melbourne Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2005

First Posted

October 4, 2005

Study Start

January 1, 2003

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

AU(1)