SAFER Trial
Research type
Research Study
Full title
The SAFER Trial: Screening for Atrial Fibrillation with ECG to Reduce stroke - a randomised controlled trial
IRAS ID
272184
Contact name
Jonathan Mant
Contact email
Sponsor organisation
University of Cambridge
Duration of Study in the UK
6 years, 8 months, 30 days
Research summary
Atrial fibrillation (AF) is a heart condition that causes irregular heartbeat. It affects up to 1 in 10 people over the age of 65. AF greatly increases risk of stroke, but treatment with blood thinning (“anticoagulant”) medication can stop this happening. About 10% of strokes happen in people unaware they have AF. Detecting AF can be difficult because it often comes and goes, and may not cause symptoms.
Many clinicians think the NHS should promote AF screening. The UK National Screening Committee has highlighted a lack of evidence that detecting AF in people by screening would benefit them.
We are therefore undertaking a large 8-year programme of work to find out if screening for AF in people aged 65 and over does prevent stroke and other problems like heart attacks, does not cause significant harm, and represents good value-for-money for the NHS. The SAFER Trial is a cluster randomised trial that will address these questions.
The SAFER Trial will take place in 360 UK GP practices and include about 126,000 people. Practices will be randomised to control or screening (2:1). Consented participants in screening practices will be invited to be screened for AF. Participants will use a handheld single-lead ECG recorder to record ECGs at home over a period of 3 weeks. The ECGs will be read by a validated computer algorithm, with diagnoses confirmed by a cardiologist. Participants diagnosed with AF will be invited to a GP appointment to discuss treatment with blood thinning (anticoagulant) medication.
As part of this study we will conduct qualitative multi-method case studies in some practices. These will include interviews with patients, with GP practice staff and external stakeholders, and practice observations.
REC name
London - Central Research Ethics Committee
REC reference
19/LO/1597
Date of REC Opinion
25 Oct 2019
REC opinion
Further Information Favourable Opinion