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
Randomised controlled trial (RCT) of dietary intervention to sustain sinus rhythm in patients following initiation of treatment for atrial fibrillation or flutter
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/15533612
Publication citations
-
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.