Randomised controlled trial (RCT) of dietary intervention to sustain sinus rhythm in patients following initiation of treatment for atrial fibrillation or flutter
| ISRCTN | ISRCTN16448451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16448451 |
| Protocol serial number | RHC11281 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive North West (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 26/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Peter Elton
Scientific
Scientific
Wigan & Bolton Health Authority
Bryan House
61 Standishgate
Wigan
WN1 1AH
United Kingdom
| Phone | +44 (0)1942 772711 |
|---|---|
| peter.elton@wab-ha.nwest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial (RCT) of dietary intervention to sustain sinus rhythm in patients following initiation of treatment for atrial fibrillation or flutter |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Atrial fibrillation and flutter |
| Intervention | 1. Addition of fish oil to the diet 2. Maintenance of normal diet |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome measure will be the number of patients in sustained sinus rhythm for a period of 12 months. |
| Key secondary outcome measure(s) |
1. Mortality associated with coronary heart disease |
| Completion date | 01/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Key inclusion criteria | Inpatients and outpatients aged 18 years and above, recently diagnosed as having atrial fibrillation or flutter, as determined by electrocardiogram (ECG). |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/07/1998 |
| Date of final enrolment | 01/07/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wigan & Bolton Health Authority
Wigan
WN1 1AH
United Kingdom
WN1 1AH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2005 | Yes | No |
Editorial Notes
26/10/2018: No publications found, verifying study status with principal investigator.
