The study will consist of 70 patients who are living with hypertrophic cardiomyopathy (HCM) and will involve determining if regimented moderate intensity exercise can improve overall exercise capacity and cardiac blood flow.
In order to track the progress of participants, the trial will use Vivalink’s biometric data platform, which consists of a wearable electrocardiogram (ECG) sensor and a cloud data platform that tracks electrical activity. The reusable sensor will continually capture ECG and heart rate data from participants 24 hours a day, which will be processed by the platform.
Vivalink states that the biometrics platform allows for data to be delivered from any location for centralized analysis and processing, from which clinical insights can then be delivered, in real-time or retrospectively.
In addition to capturing ECG rhythm and heart rate, Vivalink’s sensor can also monitor heart rate variability, respiratory rate and offer accelerometer data.
Vivalink’s portfolio of wearables allows for data capture in virtual healthcare and decentralized clinical trials. This allows the company to provide tracking for CG rhythm, heart rate and variability, respiratory rate, axillary and skin temperature, oxygen saturation, blood pressure, and other measurements.
According to the company, its wearables have been adopted by over 200 commercial partners in more than 40 countries.
UCSF’s Theodore Abraham, co-director of UCSF HCM Center of Excellence, stated that the use of Vivalink’s wearables and data services would allow the clinical trial to find ‘accurate endpoints’, while the trial itself has been set up to identify ways to prevent adverse health events for the patients.
HCM is a common inherited heart condition, with estimates that it affects approximately 1 in 500 people. The condition can lead to heart failure and atrial fibrillation, and is one of the common causes of sudden death in young athletes.
Beyond cardiovascular functions, Vivalink’s wearable can also be used for in-hospital patient monitoring, remote patient monitoring, and chemotherapy event detection.
Earlier this year, Vivalink announced that it had also partnered with Elevate Addition Services, a drug and alcohol rehabilitation center, to monitor patients during in-patient detox treatment. Through its blood pressure cuff, the company’s wearable device is able to provide continuous tracking of a patient’s vital signs.
