The Site-less Trial Commences with the Heartline Study Powered by Apple, Evidation Health & Janssen (J&J)

The Site-less Trial Commences with the Heartline Study Powered by Apple, Evidation Health & Janssen (J&J)

Johnson & Johnson’s Janssen Pharmaceutical unit inked a partnership with Apple to leverage the iPhone and FDA-complaint apps for a new study—the Heartline Study—designed to assess if apps on the iPhone and features on the Apple Watch can improve health outcomes such as the reduction of risk of stroke via the earlier detection of atrial fibrillation (AFib).

Apple a Key Player in Digital Health

Apple has emerged as a fundamental player in enabling decentralized clinical trials with its products (iPhone, Apple Watch) and associated Apps designed to be consumed via these products.

The Heartline Study

The major companies opened up the new Heartline Study, so that the industry sponsor, Janssen Scientific Affairs, LLC can identify and diagnose Atrial Fibrillation (AF) while also evaluate improvement in cardiovascular outcomes as well as improve direct oral anti-coagulant (DOAC) adherence and persistence to ultimately better characterize participants and identify predictors of disease.

The study commenced in February 2020 and runs until December 29, 2023. Known officially as the “A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-World Environment.” The study team leverages the Heartline Study smartphone app, J&J through its Janssen affiliate have initiated recruiting and enrolling participants—age 65 and over covered by Medicare. With a goal of enrolling 150,000 participants, the program is supported by research data firm Evidation Health

The study team randomizes participants from two groups, including 1) a group that will only use the Heartline Study app, and 2) a group that will sue the app plus an Apple Watch, along with its ECG and arrythmia notification features. The sponsors will provide no drugs in this trial. During the duration of the study participants shall receive heart health education and counseling, health wellness informational guidance, and surveys via the app every week. Participants won’t have to travel to any research site making it truly a decentralized, remote trial. Study sponsors will collect data thereafter based on Medicare claims. See the study website

The Heartline Executive Committee

The Heartline Study is a site-less study but it most definitely involves leading researchers and principal investigators as part of the Executive Committee team. The two co-chairs include C. Michael Gibson, MD, Professor of Medicine, Harvard Medical School and John A. Spertus, MD, Chair and Professor, University of Missouri.

Apple Moves Deeper into FDA-Regulated Digital Health

Back in September 2018, Apple won approval by the FDA for their ECG app, a software-only mobile medical application that can analyze pulse rates for irregular rhythms. With that momentum the Silicon Valley giant’s health-related business development group started inking a number of strategic partnerships involving medical research and clinical studies as well as direct alliances with device manufacturers such as Zimmer Biomet for use of the Apple Watch and iPhone to help engage patients to support them through major procedures and surgeries.

Evidation Health

Founded in 2012, Silicon Valley-based Evidation Health represents a new kind of health and measurement firm offering the world’s most innovative life science and health care companies the technology expertise necessary to understand how everyday behavior and health interact. The firm has capitalized on the explosive growth of use of smart phones and devices in day-to -day life. They note that the volume of behavior data generated from smartphones and connected sensors—including wearables and devices—has opened up new ways to analyze individual’s behavior and health in real time, unlocking insights into what medicines and treatments work best and spotting significant changes in health earlier. The company has raised over $60 million and operates in the nexus of an incredibly hot and growing space. Evidation Health employs approximately 200.