Published April 8, 2020
A three-year national study will explore whether earlier diagnosis of atrial fibrillation, combined with appropriate treatment, can improve health outcomes — including reducing the risk of stroke.
The Heartline Study, a collaboration between Johnson & Johnson and Apple, is a first-of-its-kind, virtual study designed to explore whether an iPhone app and Apple Watch can help reduce the risk of stroke by regularly monitoring study participants’ heart rhythms.
Atrial fibrillation, which is a quivering or irregular heartbeat, is one of the leading causes of stroke.
According to the Centers for Disease Control and Prevention, approximately one out of every 20 deaths in the U.S. — or 140,000 fatalities annually — is caused by stroke.
The American Heart Association estimates that at least 2.7 million Americans are living with atrial fibrillation. Unfortunately, many patients are unaware they have the condition.
“What we hope to learn here is whether diagnosing atrial fibrillation early, before a patient even knows he or she has it, and instituting treatment can prevent future strokes,” explains SUNY Distinguished Professor Anne B. Curtis, MD, who is serving on the Heartline Study executive committee.
Curtis, who has a long-standing interest in digital health and has conducted previous studies on atrial fibrillation detection, is the Charles and Mary Bauer Professor and chair of medicine. She is also president and chief executive officer of UBMD Internal Medicine.
Participants in the study — U.S. residents 65 or older who have Original Medicare — will use iPhones and allow the researchers to access their Medicare claims data. They will be randomly assigned to one of two groups.
One group will participate by only using the Heartline Study app on their iPhone. The other group will participate by using the study app on their iPhone in addition to using an Apple Watch, which they may lease if they do not own one, to access the watch’s electrocardiogram app and irregular rhythm notification feature. During the course of the study, participants’ heart rhythms will be routinely monitored.
The hope is that increased awareness will lead to better compliance with appropriate treatments.
Curtis explains that data will be stored on participants’ phones and then transmitted securely to a third-party representative for storage.
The virtual study model is designed to break down some of the barriers to participation in traditional “brick and mortar” studies. It will allow participants to take part in the study remotely, without time-consuming and often costly trips to clinical testing sites. Thus, it will help to ensure participation by a broader, more inclusive group of subjects.
The study will consist of two years of active engagement followed by one year of additional data collection.
Participants will receive educational materials, surveys and questionnaires on a weekly basis. The study will measure the impact of educational materials delivered via the Apple devices, as well as the impact of an earlier diagnosis on clinical outcomes.
It will also build a longitudinal health data repository containing all study data.
Study organizers expect to recruit 150,000 participants from across the country. Information about the study website is being circulated to physicians through social media, Curtis says.
The 13 members of the committee also are spreading the word in their own communities. The committee includes representatives from such institutions as Northwestern University, Stanford University, University of Missouri, Duke University, Harvard University and the Cleveland Clinic.
Curtis hopes doctors in Western New York will encourage eligible patients to participate in the study.
“We do have a higher-risk population in Western New York, as atrial fibrillation is more common in older patients, obese patients, and those with heart failure, sleep apnea and hypertension,” she says. “Undiagnosed, it can lead to stroke.”