Apple and Johnson & Johnson have announced a new study designed to explore if the Heartline Study app on the iPhone and heart health features on the Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection of atrial fibrillation (AFib).
Fib, a common form of irregular heart rhythm, is a leading cause of stroke in the U.S. More than 33 million people worldwide and up to six million Americans live with AFib, according to the CDC, yet up to 30 percent don't even know they have it until a serious cardiovascular event, such as a stroke, occurs.
One of the key objectives of this nationwide, randomized study is to assess if a heart health engagement program provided through the Heartline Study app on iPhone, in combination with the ECG app and the irregular rhythm notification feature on Apple Watch, can reduce the likelihood of stroke and improve health outcomes with the earlier detection of AFib.
According to company officials, the engagement program, via the Heartline Study app from Johnson & Johnson, will aim to provide ongoing education, tips, surveys and questionnaires across many topics related to overall heart health throughout the two-year active engagement period. This period will be followed by one year of additional data collection.
Officials noted that the ECG app can classify an electrocardiogram as sinus rhythm or AFib. What’s more, they contend, the irregular rhythm notification feature will provide notifications of irregular heart rhythms suggestive of AFib.
About a year ago, researchers from the Stanford University School of Medicine presented the findings of a virtual study of more than 400,000 participants revealing that the Apple Watch could detect AFib. That study had multiple key findings, including that 84 percent of the time, participants who received irregular pulse notifications were found to be in atrial fibrillation at the time of the notification.
It should also be noted, however, that some cardiologists have expressed concern “that widespread use of the watch would lead people to undergo unnecessary tests and treatment, either because of false alarms or because they have atrial fibrillation that carries a lower risk of complications.”
Through the app-based approach, the Apple/J&J study will enable participants to engage in the study remotely, right from their iPhone and in some cases an Apple Watch, rather than travel to a clinical trial site.
To enroll in the Heartline Study, individuals must be age 65 or older, a U.S. resident, have original (traditional) Medicare, own an iPhone 6s or a later model, and agree to provide access to their Medicare claims data.
A deeper dive into the study by CNBC found that the goal is to recruit at least 150,000 people who will be randomly assigned into one of two buckets: either they will be navigated through the iPhone Heartline app, or they’ll be given the Apple Watch, either as a loaner device or at a heavily subsidized price of $49 plus tax. The Apple Watch Series 5 normally retails for $399.
"Heartline is a study that has the potential to fundamentally change our understanding of how digital health tools, like the ECG app and irregular rhythm notification feature on Apple Watch, could lead to earlier detection of AFib, helping patients understand and directly engage in their heart health, prompting potentially life-saving conversations with their doctors, and improving health outcomes," C. Michael Gibson, M.D., co-chair of the Heartline Executive Committee and professor of medicine, Harvard Medical School and CEO, Baim Institute, said in a statement.