Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Elton

ORCID ID

Contact details

Wigan & Bolton Health Authority
Bryan House
61 Standishgate
Wigan
WN1 1AH
United Kingdom
+44 (0)1942 772711
peter.elton@wab-ha.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC11281

Study information

Scientific title

Acronym

Study hypothesis

Effectiveness of policy of providing dietary instruction to eat oil rich fish to maintain sinus rhythm.
To increase sustained sinus rhythm following cardioconversion in patients to be cardioverted for atrial fibrillation or flutter.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Atrial fibrillation and flutter

Intervention

1. Addition of fish oil to the diet
2. Maintenance of normal diet

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure will be the number of patients in sustained sinus rhythm for a period of 12 months.

Secondary outcome measures

1. Mortality associated with coronary heart disease
2. All mortality
3. Coronary heart disease related morbidity & number of strokes
4. Quality of life assessment
5. Suitability of dietary instructions
6. The patients perception of any change in weekly shopping bills
7. An economic analysis through consultation with a Health Economist.

Overall trial start date

01/07/1998

Overall trial end date

01/07/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Inpatients and outpatients aged 18 years and above, recently diagnosed as having atrial fibrillation or flutter, as determined by electrocardiogram (ECG).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/07/1998

Recruitment end date

01/07/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wigan & Bolton Health Authority
Wigan
WN1 1AH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15533612

Publication citations

  1. Protocol

    Harrison RA, Elton PJ, Is there a role for long-chain omega3 or oil-rich fish in the treatment of atrial fibrillation?, Med. Hypotheses, 2005, 64, 1, 59-63, doi: 10.1016/j.mehy.2004.06.016.

Additional files

Editorial Notes