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Press Release: Samsung, Huma and Tulane University’s HEARTBEAT 10,000 Study Enrolls First Patient 

Created: 12.16.2024

 

  • The HEARTBEAT study, sponsored by Samsung and conducted by Tulane University, explores the potential of wearable technology in predicting, preventing and understanding cardiovascular diseases (CVD). 

  • The study will use an end-to-end decentralized approach for data collection. Alcedis, the clinical trial unit of Huma, created the technical platform that streamlines data exchange between electronic health records (EHR), clinical study database, patient app and wearables of 10,000 eligible subjects.  

  • Standing out due to its fully decentralized clinical trial (DCT) approach, this project is bound to lay the groundwork for a new era of cardiovascular disease prevention and management 

 

New Orleans, LA, [12/16/2024] – Samsung and Tulane University’s research center TRIAD have announced the successful enrollment of the first patient in their groundbreaking HEARTBEAT study. The large-scale clinical trial will explore the potential use of smartwatches in collecting and analyzing biometric data to improve the detection, identification, and understanding of cardiovascular diseases and related conditions. 

The HEARTBEAT study, which Samsung showcased at the HLTH 2024 conference in Las Vegas, stands out due to its fully decentralized clinical trial (DCT) approach. The 10,000 adult participants will be remotely monitored over a one-year period, using the Samsung Galaxy Watch 6 to collect biometric data such as heart rate, oxygen saturation, and physical activity. This remote approach ensures accessibility, especially for underserved communities, by providing LTE-enabled smartwatches to participants lacking Wi-Fi access, allowing seamless data collection regardless of location. 

In collaboration with Huma and its research unit Alcedis, the study utilizes a sophisticated data platform to facilitate seamless integration between the smartwatch, electronic health records (EHRs), the clinical study database, and a patient app. Participants will use this app to complete baseline and follow-up questionnaires on medical history, medications, quality of life, and sleep patterns, ensuring comprehensive data capture throughout the study duration. 

Dr. Nassir Marrouche, Director of the Tulane Research Innovation for Arrhythmia Discovery Center (TRIAD), the Tulane University Heart and Vascular Institute (TUHVI), and principal investigator of the HEARTBEAT study, says: “Although medical treatments have seen consistent advancements, the emphasis on prevention and early detection of cardiovascular diseases remains the cornerstone for enhancing outcomes. Traditional approaches, which focus on clinical, laboratory, and imaging markers, often identify conditions at a stage where irreversible damage may have already occurred. By leveraging advanced analytics and machine learning algorithms on smartwatch-derived biometric data, we are working to identify patterns in biometric signals and markers that precede the onset and progression of cardiovascular conditions. This approach lays the groundwork for a new era of cardiovascular disease prevention and management—one that is proactive, personalized, and predicated on the earliest possible detection of risk.” 

Huma CEO & Founder Dan Vahdat commented: "The HEARTBEAT study showcases how cutting-edge technologies like smartwatches, patient apps, and electronic health records (EHRs) can seamlessly integrate to transform the way we collect and analyze health data. By leveraging artificial intelligence and machine learning within this ecosystem, we are unlocking new possibilities for predictive analysis, enabling early detection of cardiovascular disease risks. This is a major step toward a future of preventive and personalized healthcare." 

 

 

ABOUT SAMSUNG 

Samsung Electronics is a global leader in technology, opening new possibilities for people everywhere. Through relentless innovation and discovery, we are transforming the worlds of TVs, smartphones, wearable devices, tablets, digital appliances, network systems, medical devices, semiconductors and LED solutions. Samsung is also leading in the Internet of Things space through, among others, our Smart Home and Digital Health initiatives. 

Since being established in 1969, Samsung Electronics has grown into one of the world’s leading technology companies, and become recognized as one of the top 10 global brands. Our network now extends across the world, and Samsung takes great pride in the creativity and diversity of its talented people, who drive our growth. 

 

ABOUT TULANE UNIVERSITY / TRIAD 

A member of the prestigious Association of American Universities, Tulane University is consistently ranked among the top 50 universities in the nation. With research and educational partnerships that span the globe and its location in historic New Orleans, Tulane offers undergraduate, graduate and professional degrees in the liberal arts, science and engineering, architecture, business, law, social work, medicine and public health and tropical medicine. 

The Tulane Research Innovation for Arrhythmia Discovery Center (TRIAD) is a multi-disciplinary center bringing together different departments from epidemiology, Computer Science, Biomedical Engineering, Neurology and Cardiology to focus on innovation and discoveries in the field of Cardiovascular Medicine. 

 

ABOUT HUMA 

Huma is a global healthcare AI company on a mission to accelerate the adoption of digital solutions in care and research. Huma’s technology powers over 4,500 hospitals and clinics globally and has screened, triaged, and engaged over 50 million individuals across 70+ countries. The company plays a pivotal role in national healthcare projects across the US, UK, Germany, Greece, and Saudi Arabia and collaborates with leading pharmaceutical companies and CROs. 

Huma’s solutions are live in more than 80 NHS Trusts and across two-thirds of primary care practices. The Huma Cloud Platform is built on a strong regulatory foundation, achieving FDA 510(k) Class II, EU MDR Class IIb, Saudi FDA Class C, and India CDSCO Class C clearances, making it a robust platform to launch healthcare solutions quickly and safely. 

 

ABOUT ALCEDIS 

Alcedis is a leading clinical research organization (CRO) dedicated to advancing clinical research through innovative digital solutions and comprehensive support for clinical studies. Being a proud member of the Huma Group, we strive to enable faster, more efficient research processes by bridging the gap between innovation and real-world application in healthcare, driving progress in drug development and patient care forward. 

With over 30 years of experience, Alcedis combines full-service clinical trial expertise with disruptive technologies, pioneering data-driven studies from phase I through drug approval, and beyond market access into real-world evidence.  

 

A report by WWL-TV:

https://www.youtube.com/watch?v=feTPByzSuQk