Study FAQ
The purpose of the AMALFI study is to see whether wearing a new home monitor called a Zio Patch, which can give a continuous heart trace reading for two weeks, will increase the number of people we can detect with atrial fibrillation.
Diagnosing atrial fibrillation is normally done using an electrocardiogram (ECG) which catches the heart rate at a single point in time. However, as atrial fibrillation may only be happening some of the time this test might not always detect atrial fibrillation if by chance the heart is beating regularly when the ECG is done.
The hope is that using the Zio Patch would allow more people to be put on the right treatment at an earlier stage and so bring down their risk of having a stroke.
The AMALFI study has been designed and is run by researchers at the University of Oxford’s Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) and the Division of Cardiovascular Medicine, which are world-leading centres for this type of work. The study is led by Professor Louise Bowman and Professor Barbara Casadei and involves local cardiology and General Practice specialists as well as partnership work with many other local doctors, nurses and healthcare professionals.
The study has been approved by an independent research ethics committee, which includes medical professionals and members of the general public. The ethics committee has reviewed all the study documentation as well as checking that the question the study is hoping to answer is important enough to warrant the research being undertaken.
AMALFI has been designed by the University of Oxford, who run the study independently of any funders. The funding itself comes through the National Institute for Health and Care Research Oxford Biomedical Research Centre and the British Heart Foundation with additional support from iRhythm, who donated the Zio patches free of charge.
The AMALFI study has been designed to see if using the Zio Patch, will increase the number of people detected early with atrial fibrillation and therefore to bring down their risk of having a stroke. To do this we recruited 5040 people, half of whom were asked to wear a patch and half of whom didn’t need to.
The reason for this approach is because we need to compare different treatments to find out which one is best for patients, so we divide participants into groups and give each group a different treatment. The groups are then compared to see if one treatment is better.
In AMALFI, we will count how many people are diagnosed with atrial fibrillation over the next five years and analyse if there was any difference between those who had a patch and those who didn’t.
When the main analysis (taken from 2.5 and 5 years) has been completed, we will inform you and your GP of the results. We plan to publish the results of the study in professional medical journals and also to present them to international healthcare audiences. No personally identifiable information will be published or presented at any time. If the study shows this approach to screening appears to be successful and cost-effective we will consider how to implement screening on a larger scale across the United Kingdom including the feasibility of a national screening programme.