SCREEN AF-DZHK15


Study information
SCREEN AF-DZHK15

Recruiting status

Recruiting complete, follow-up complete

Recruitment start

12/2017

Patients

301

267

Clinical Trials Registration

NCT02392754

Category

Guideline relevant study

DZHK Funding

EUR 636.691,22

Links

https://clinicaltrials.gov/ct2/show/NCT02392754

Operative contact
Main study centre
Katharina Schmalstieg-Bahr, MD
k.schmalstieg-bahr@uke.de

Studienzentren/Kontakt (PDF)

Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older (SCREEN AF-DZHK15)

The SCREEN-AF study aims to improve the early detection of atrial fibrillation using a new “rhythm patch” with an integrated ECG recording unit which is applied to the patient’s chest. This patch has a mini monitor as a recording unit which can record the heart rhythm for up to two weeks. In comparison to conventional Holter ECGs, this recording method is less cumbersome for the study participants and they can, for example, even shower without having to remove the patch. In addition, the study participants take their blood pressure twice a day with a blood pressure monitor suitable for home use. The study examines whether early atrial fibrillation can be detected with the help of two 2-week continuous ECG recordings.

Besides investigating how often atrial fibrillation is detected, the study investigators also want to ascertain how often and how long they need to measure in order to capture all cases. For this reason, the 14-day ECG recordings and blood pressure measurements are repeated after three months, and after six months the general practitioner examines the heart of the patients.

The study is directed towards patients aged 75 or older who have high blood pressure, but so far have shown no indication of an arrhythmia. The study team cooperates closely with a network of general practitioners with whose help patients are recruited.

Atrial fibrillation is responsible for a quarter of all strokes, and yet the risk of patients with atrial fibrillation having a stroke can be reduced by 70 percent if they take anticoagulants early enough. The problem is an early diagnosis because often the heart only beats irregularly in paroxysmal episodes, which does not cause any discomfort.

Except for the management of risk factors such as obesity, high blood lipid levels or high blood pressure, there is currently no standard stroke prevention program involving screening for atrial fibrillation. The SCREEN-AF study is a first step in developing such a program for primary stroke prevention. It is being conducted in cooperation with the Canadian Stroke Prevention Intervention Network (C-SPIN), who together with the DZHK is funding the study.

Publications

Screening for Atrial Fibrillation in the Older Population A Randomized Clinical Trial. Gladstone, DJ. et al. JAMA Cardiology 2021, doi: 10.1001/jamacardio.2021.0038. https://jamanetwork.com/journals/jamacardiology/article-abstract/2776728

All publications here

Principal Investigators

Prof. Dr. med. Rolf Wachter
Universitätsklinikum Leipzig
Prof. Jeff Healey
David Gladstone
Canadian Stroke Prevention Intervention Network

Press releases and news

DZHK Study: Recognising atrial fibrillation earlier and reducing strokes

A new clinical study on the early detection of atrial fibrillation at home is starting at the German...

Wearable heart monitor effective for early detection of atrial fibrillation (Study SCREEN-AF-DZHK15)

A small, wearable heart monitor can detect atrial fibrillation in high-risk patients ten times more...

Study recruitment is available in these cities

The map only displays recruitment locations within Germany.