SCREEN-AF − Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older: the SCREEN-AF Randomized Trial

Atrial fibrillation (VHF) is one of the most common, treatable causes of stroke, but is usually difficult to diagnose because VHF is often clinically inapparent and intermittent. The development of new monitoring technologies for the ambulatory setting has the potential to improve early detection of VHF.

Aim and question

The overall aim of the study is to develop a feasible and cost-effective VHF screening strategy that can be applied in outpatient primary care settings.

The hypothesis is that continuous ambulatory cardiac rhythm monitoring using stick-on ECG patches is superior to the standard method of VHF detection (no screening). The inclusion process is complete. Data analysis is ongoing.

Methods

SCREEN-AF is an investigator-initiated, multicenter, randomized controlled trial. The target population is patients 75 years of age and older with diagnosed hypertension and no known AF who would also be eligible for anticoagulation therapy if AF were found. Participants were recruited through their respective family practice and randomized 1:1 to one of the two groups:

The control group received standard primary care for 6 months (no VHF screening).

The intervention group underwent outpatient VHF screening, wearing a stick-on ECG monitor (ZIO patch) continuously for 2 weeks at the time of inclusion and after 3 months, in addition to standard GP care. The intervention group also received a home blood pressure monitor with automatic VHF detection (WatchBP), which participants* were asked to use to measure their blood pressure twice a day during the 2-week ECG monitoring period.

Funding

The study is sponsored in Germany by the German Center for Cardiovascular Research (DZHK). The manufacturer of the ZIO patch (iiRhythm) provided the devices but did not financially support the study.

Registration

Study registration:

www.clinicaltrial.gov (Identifier: NCT02392754)

Contact

Direktorin

Prof. Dr. Eva Hummers

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