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Johnson & Johnson announced Tuesday that its Janssen Pharmaceutical unit and Apple have opened enrolment for their previously announced "first-of-its-kind" virtual study designed to explore if Johnson & Johnson's Heartline Study app on iPhone, used in conjunction with heart health features on Apple Watch, can improve health outcomes, including reducing the risk of stroke, by detecting atrial fibrillation (AF) earlier. Commenting on the delay between disclosing the study early last year and starting enrolment, Johnson & Johnson said it has "taken the time to build a landmark study."
According to the company, "through the app-based approach, [Heartline] 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." It added that in this way, "the cost is reduced and the speed at which we are acquiring useful data is dramatically faster. This allows us to study more patients more quickly…[and] also democratises participation."
Paul Burton, vice president of medical affairs and internal medicine at Janssen Scientific Affairs, remarked that through the collaboration with Apple, a first between the companies, "we are pioneering new models that we hope can break down some of the most common barriers to participation in clinical studies."
The US-based study is open to participants aged 65 years and older, with or without an existing AF diagnosis, who can download the Heartline Study app on their iPhone. One of the key objectives is to assess if a heart health engagement programme provided through the study app, in combination with the Apple Watch's electrocardiogram (ECG) app and irregular rhythm notification feature, can reduce the likelihood of stroke and improve health outcomes with earlier AF detection. The engagement programme "will provide ongoing education, tips, surveys and questionnaires across many topics related to overall heart health throughout the two-year active engagement period," Johnson & Johnson said.
Participants will be randomised to one of two groups, with one participating by only using the Heartline Study app on their iPhone, and the other by using the study app on their iPhone in addition to obtaining an Apple Watch to use the ECG app and irregular rhythm notification feature. Participation will span a total of three years, with two years of active engagement, followed by one year of additional data collection.
Apple received de novo classification from the FDA for the ECG feature on the Apple Watch in 2018. The feature has been used in the Apple Heart Study to detect AF. The ECG app and irregular notification feature on Apple Watch have also been launched in Europe and Hong Kong.
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