Trial to Test Smart Watch to Guide Blood Thinners

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30 Aug. 2022. A clinical trial is planned to test heart rhythms measured with an Apple smart watch to guide use of blood thinning medicines in people with irregular heartbeat. The trial is funded initially by a $3.6 million grant to Northwestern University medical school from National Heart, Lung, and Blood Institute, or NHLBI, part of National Institutes of Health.

The study aims to determine if a wearable device like a smart watch can help target the taking of anticoagulation drugs, also known as blood thinners, by people with atrial fibrillation, a form of irregular heartbeat. Atrial fibrillation is a disorder where the upper chambers of the heart, known as the atria, beat in irregular patterns instead of the normal smooth regular beat. As a result, regular blood flow is interrupted allowing for blood to pool in the atria and form clots, which can then move to the brain and cause a stroke.

Many people with atrial fibrillation, says American Heart Association, do not display symptoms and thus are unaware of their condition. AHA estimates as many as one in five strokes are a result of atrial fibrillation, yet the group cites a 2009 survey showing less than half of people with atrial fibrillation believe they face an increased risk of stroke or heart failure.

A common treatment for atrial fibrillation is anticoagulation drugs to break up clots that may form in the atria. The medications, usually oral drugs, are taken every day by atrial fibrillation patients even if irregular heartbeats occur infrequently. These drugs, however, increase the risk of excessive bruising and bleeding, thus the need for a treatment strategy that can decrease their use, while still monitoring for irregular heartbeat occurrences when the drugs can be effective.

“Save lives, reduce cost, and improve quality of life”

“Many of these patients are on blood thinners for the rest of their lives,” says Rod Passman, director of the Center for Arrhythmia Research at Northwestern and principal investigator of the study in a university statement, “even if they have infrequent episodes of atrial fibrillation. If we can show this strategy is equally protective against stroke and reduces bleeding, that could save lives, reduce cost, and improve quality of life.”

The clinical trial, says the university, will enroll some 5,400 people with atrial fibrillation, randomly assigned to take anticoagulation drugs in the usual continuous way, or have their use of anticoagulants determined by heart rhythm readings on an Apple smart watch. Apple’s Health app uses the smart watch and phone to capture a range of health data, including heart rate and irregular rhythm, as well as sleep, exercise, falls, and menstrual health. And, as reported by Science & Enterprise in June 2021, a companion Apple app is available for researchers to capture and report these data with the consent of users.

The trial seeks to determine if taking anticoagulation drugs when alerted by smart watch reports of irregular heartbeats is as effective in reducing blood clots and strokes as taking the drugs continuously. The study will also track major bleeding events by participants, as well as satisfaction of participants with their treatment strategy and their overall use of health care resources.

The clinical trial is expected to take seven years to complete. The university says NHLBI authorized funds for the first two years, with remaining funds contingent on achieving initial project milestones. Researchers at Johns Hopkins University, Stanford University, University of California at San Francisco, and American Heart Association are collaborating on the study.

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