Apple, J&J launch 150,000-person virtual study to test its ECG smartwatch and heart-focused apps

Johnson & Johnson launched a new, virtual clinical study to gauge whether Apple’s iPhone and ECG-enabled smartwatch can help reduce a person’s risk of stroke and detect earlier, hidden cases of atrial fibrillation.

Conducted entirely through the companies’ Heartline Study smartphone app, J&J and its Janssen division have begun enrolling adults age 65 and older and covered by Medicare—with the goal of building a 150,000-person cohort. The program was developed in collaboration with Apple and the research data firm Evidation Health.

“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,” said C. Michael Gibson, co-chair of the app and study’s executive committee and a professor of medicine at Harvard Medical School.

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The study will randomize participants to two groups: one that will only use the Heartline Study app, and another that will use the app plus an Apple Watch, along with its ECG and arrythmia notification features. No drugs will be given as part of the study.

Over the next two years, users will receive heart health education, wellness tips and surveys through the app each week—without needing to travel to a clinical research site—followed by an additional year of data collection based on Medicare claims.

“Through this important collaboration with Apple, we are pioneering new models that we hope can break down some of the most common barriers to participation in clinical studies,” said Janssen’s vice president of medical affairs for internal medicine, Paul Burton.

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The companies estimate that as many as 6 million people in the U.S. may live with AFib, along with over 33 million people worldwide—though about 30% may not realize it until they have a serious event such as a stroke.

A previous virtual study by Apple and Stanford Medicine was able to enroll more than 400,000 people across the U.S. in just eight months, to test the Apple Watch’s ability to detect irregular heartbeats using only its background pulse tracker.

Though only 0.5% of participants received an alert notifying them of a possible arrhythmia, that still amounted to at least 2,000 people, who were then connected with a physician for a telehealth consultation and later given an ECG-capable chest patch for further monitoring and diagnosis. About one-third of those participants were confirmed to have atrial fibrillation, though 57% went on to seek medical attention.