Apple and Johnson & Johnson’s ongoing Heartline Study aims to evaluate changes in stroke risk and atrial fibrillation (AF) detection through the use of the Heartline Study’s app and the Apple Watch.
With a target trial enrollment of 150,000 participants over the age of 65 years, 5,000 seniors signed up within the first week of the study’s initiation on 25 February.
Meanwhile, according to GlobalData’s clinical trials database, there is an overall increase in trials that have pushed back their estimated start dates since the beginning of January, largely due to the Covid-19 pandemic. However, industry experts believe remote studies such as Heartline may have a significant advantage as patients can continue to enrol and participate from their homes. GlobalData believes that the trial can continue with minimal disruptions.
Participants in the Heartline study are randomly assigned to one of two groups. The first group wears an Apple Watch and takes part in an educational program through the Heartline Study app, while individuals in the second group only use the app on their phones without the watch. The aim of the study will be to determine whether a diagnosis of AF can be made more quickly when patients receive health notifications from the app.
Key opinion leaders interviewed by GlobalData have emphasised this longstanding unmet need in the AF space related to early identification / diagnosis, especially when considering the fact that many AF patients remain undiagnosed due to being asymptomatic.
Patients who have already been diagnosed with AF will receive notifications on the app about adhering to their medication and refilling medicines. The study is expected to be the largest randomised cardiovascular study ever conducted. A previous study using the Apple Watch helped to alert people who might have been at risk of heart failure or stroke. The new Apple Watch trial is estimated to be completed by December 2023.
Across various indications, clinical trials are increasingly expected to experience delays as investigators and hospitals, which are used as clinical trial sites, are inundated with Covid-19 patients. With fewer trial sites and investigators available to run the trials, clinical trials for certain indications will be deprioritised.
Also, patients involved in these studies may soon be urged not to visit hospitals for infusions or other appointments due to the pandemic. Therefore, the Heartline Study presents the added benefit of being able to progress with the fewest interruptions, despite the US health officials advising the senior population to practice social distancing due to the Covid-19 pandemic.