New York, NY — With plans to enroll as many as 150,000 American senior citizens, Johnson & Johnson is collaborating with Apple on HEARTLINE, a revolutionary new study to detect atrial fibrillation (AFib), a potentially lethal condition that can lead to heart palpitations and stroke. Apple Watches will be given to some trial participants—not all, in order to make it randomized—and the watch’s ECG app will be used to monitor heartrates. HEARTLINE is ambitious, constituting one of the biggest efforts to date to assemble a randomized virtual trial.
HEARTLINE will build off an earlier Apple Watch–based study. In the Apple Heart Study, conducted at Stanford Medical School, 0.5 percent of participants received a notification from their trial-related app that AFib had been detected. Based on the number of participants who followed up, received an ECG patch, and had an AFib confirmed, the Apple Watch’s positive predictive value (the probability that a positive test result truly reflects the presence of the disease) was determined to be 71%. This seemingly somewhat low value is largely attributable to the low ages of participants in the trial. More than half were younger than 39, an age group considered to be very low-risk as regards AFib. In efforts to detect a low-prevalence condition, a positive predictive value would be low.
Because all of its participants will be 65 or over, the HEARTLINE study will address this issue.
According to John Whang, Head of Cardiovascular and Metabolism Integrated Evidence at Janssen, a subsidiary of Johnson & Johnson, this study could represent a significant step forward in the budding science of digital health. As he told Forbes, “We see the impact digital and wearable technologies could have on how we do our late-stage studies—accelerating and making them more efficient so we can bring life-changing treatments to patients faster that move the needle in health care.”
Why This Matters
Virtual clinical trials seem more and more like the way of the future, as they facilitate enrollment, reduce costs, and bypass many geographic and socioeconomic boundaries. If HEARTLINE empowers more patients to achieve better cardiovascular outcomes, it can be expected that new technologies will be developed to monitor other aspects of a patient’s health through their phones and, in turn, enable virtual trials across other health areas. Additionally, the breadth of sensors in smartphones makes them powerful tools for gathering real-world data about a patient in their micro-environments. This empowers innovators to determine the best therapy for them—or customize a new one.