Santé-AF feasibility study
Research type
Research Study
Full title
Sessions of Acupuncture and Nutritional Therapy Evaluation for Atrial Fibrillation: a feasibility study to inform a randomised controlled trial
IRAS ID
268585
Contact name
Judith Watson
Contact email
Sponsor organisation
University of York
ISRCTN Number
ISRCTN13671984
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Atrial fibrillation (AF) is a common cardiac rhythm disorder associated with up to five-fold increased risk of stroke. Risk factors include age, lifestyle factors, current comorbidities, hypertension and heart failure; incidence is increasing rapidly concurrent with an ageing population and unhelpful lifestyle choices, and current costs are estimated at up to 2.4% of total NHS expenditure. Current treatment options are not always successful in restoring heart rate/rhythm, and some may increase arrhythmia; adverse effects of treatment affects quality of life for some patients, additionally increasing risk of serious complications or death. Up to 50% of patients have AF recurrence within three months of treatment.
A small body of evidence suggests that traditional acupuncture and nutritional therapy are well-tolerated therapies that may offer direct benefits by reducing symptoms, and indirect benefits by improving patients’ levels of self-care.
A feasibility study is planned, to test some aspects of a large-scale trial. 30 participants of ages ≥45 and ≤70 with episodic AF will be randomised to three groups: Acupuncture + usual care; Nutritional Therapy + usual care; Usual care alone. Participants will receive up to 8 acupuncture treatments (Group 1) or up to 3 nutritional therapy consultations (Group 2) in addition to usual care, or will receive usual care alone (Group 3). Interventions will be delivered by private practitioners (members of relevant professional bodies (British Acupuncture Council and British Association of Nutritional Therapy and Lifestyle Medicine)) working to their usual codes of professional practice.
Assessments are carried out at baseline, 3 months and 6 months, and will include qualitative and quantitative self-report questionnaires and interviews; anthropometric data; symptom diaries; ECG monitoring for 33% of participants. All measurements relate to objectives of feasibility except the AFEQT questionnaire and AF symptom diary, which will be analysed to support the decision to progress to a future definitive trial.REC name
London - Surrey Research Ethics Committee
REC reference
20/LO/0598
Date of REC Opinion
3 Nov 2020
REC opinion
Further Information Favourable Opinion