hat happens when you bring together top cardiologists, powerful technology and the deep healthcare expertise of the Janssen Pharmaceutical Companies of Johnson & Johnson?
You have the makings of the dream team behind the innovative Heartline Study, a nationwide research initiative that aims to determine whether an app-based heart health engagement program, used in combination with Apple Watch’s irregular rhythm notification and electrocardiogram (ECG) app, can potentially help lead to the earlier detection and diagnosis of atrial fibrillation (AFib)—and ultimately reduce the likelihood of stroke.
AFib is a type of irregular heart rhythm that occurs when the heart’s upper and lower chambers do not beat in sync. As a result, blood clots can develop in the heart and travel to the brain, making AFib one of the most common causes of stroke. There are many unknowns around AFib, and because there are often no symptoms, many people who have it remain undiagnosed.
But if doctors are able to identify and treat AFib earlier, they may be able to reduce the risk of these fatal and disabling strokes, says cardiologist C. Michael Gibson, M.D., CEO of the Baim Institute for Clinical Research and founder of the Perfuse Study Group at Harvard Medical School. That’s why Gibson—who's studied cardiovascular health for 38 years—is consulting with Johnson & Johnson and co-leading the multiyear virtual Heartline Study with cardiologist John Spertus, M.D., the Daniel J. Lauer/Missouri Endowed Chair in Metabolic and Vascular Disease Research at the University of Missouri–Kansas City.
As the study starts enrolling participants, we spoke with Gibson about what makes the study so innovative and how it has the potential to change the way clinical trials are conducted in the future.
I had a family member who felt some symptoms of irregular heart rhythm. Using data from his Apple Watch to support our clinical decision-making, we were able to help diagnose his problem and get him the care he needed. With this study, we hope to be able to do that on a mass scale.ShareDid you like reading this story? Click the heart to show your love.
Can you talk about the importance of the Heartline Study? Why the focus on atrial fibrillation in older adults?
Secondly, we have an aging population, so there are more and more older patients around the world. These are exactly the patients who are at the highest risk of atrial fibrillation, which is associated with a significant increase in the risk of stroke—but the good news is that these strokes may be preventable.
By having the study focus on the highest risk patients, my hope is that we can potentially help participants improve their heart health.
How will the study help diagnose atrial fibrillation?
Not long ago, I had a family member who felt some symptoms of irregular heart rhythm. Using data from his Apple Watch to support our clinical decision-making, we were able to help diagnose his problem and get him the care he needed. With this study, we hope to be able to do that on a mass scale.
Some participants in the study will wear an Apple Watch, which can detect irregular heart rhythms through a sensor. They will also get access to the Heartline Study app for iPhone that serves many functions, including providing helpful education information if the participant gets an alert notifying them of irregular heart rhythms that may be consistent with AFib. If participants receive one of these alerts, they will be encouraged to take the ECG available on the Apple Watch and seek advice from a healthcare provider.
When it's triggered by certain events—such as a lack of engagement with the program or a confirmed AFib diagnosis by a medical provider—the app will also automatically adjust the heart health education materials it delivers to the participant to provide useful follow-up information. In the future, the technology may also generate data that may be used to discover new predictors for conditions. And for some participants who've already been prescribed blood thinners, the app will also provide educational materials to hopefully support the patients' adherence to their medication regimens.
What if the participant doesn’t see a doctor after being notified of an irregular heart rhythm?
The decision to take action is the responsibility of the participant, but the Heartline Study app will provide additional prompting and educational materials to help people make informed decisions.
I’m excited about this part of the study because, as physicians, we need to get a better handle on how often that lack of action happens. While it’s clear that patients often don’t take the medicines they’re prescribed—and, in fact, often don’t even pick them up from the pharmacy—this study could provide more solid data and help us learn more about how often patients don’t respond to warnings about abnormalities in their health.
We’ll be able to compare the outcomes of those people who do respond to the alerts to those who don’t. We may also find some common characteristics among people who don’t respond. Maybe they're older. Maybe they have other medical conditions.
We hope to probe that deeply so that we can identify and help alleviate those kinds of barriers to seeking care. Data is only the beginning—ultimately we in the medical community also have to help people change their behavior, so they take corrective action, when appropriate.
The hope is that a wearable device could detect an irregular heart rhythm earlier. It could act like a warning light that allows a mechanic to detect whether something’s wrong before the car actually breaks down.ShareDid you like reading this story? Click the heart to show your love.
What makes the design of this study so innovative compared to a typical clinical trial?
Traditional trials typically require multiple sites, frequent visits to a physician’s office or hospital, and can be very expensive.
Because we’re conducting the Heartline Study virtually, using mobile health technology, 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. As a result, we will hopefully be able to get to good ideas faster.
A virtual study also democratizes participation. In traditional clinical studies, patients need to live near a research hospital or be able to take time out of their schedules to go to a doctor or testing facility to be monitored.
Because participants will enroll over the internet and send data virtually, patients aren’t limited by where they live and can still have access to a study that's led by world-class experts. And we hope to be able to learn a great deal about patients.
We hope to learn how much they move, their health habits and environment, as well as their overall health or lack of health. We always talk about the genome, but this will give us insight into the exposome: What are patients exposing their bodies to in terms of movement and healthy or unhealthy activities?
Of course, even though we are collecting all this information, participant privacy and data security are of the utmost priority for everyone involved in the project. Safeguards are in place to restrict who gets access to what data and for what purpose.
How could the information gleaned from this study help save lives?
There are many questions to be answered with the study, but the biggest is whether earlier detection of AFib can improve cardiovascular outcomes, including stroke. That’s one of the questions we hope to explore in a study of this size.
Right now, we rely on symptoms—such as quivering, fluttering or irregular heart rhythm—to detect AFib. But the hope is that a wearable device could detect an irregular heart rhythm earlier, since people may not be able to recognize symptoms without assistance. It could act like a warning light that allows a mechanic to detect whether something’s wrong before the car actually breaks down.
The question is, if a person responds to this heart-health warning light earlier, will it keep their body running better and longer?