NCT06753045

Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology

Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

Summary

This is a phase 0, non-interventional, longitudinal, electronic data capture (EDC) study to facilitate the HEARTBEAT Study project has set out to 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 by SAMSUNG and Tulane. The study will include up to ten thousand adult subjects tasked with wearing a smartwatch to collect digital biomarker data over a 1 year period. Concurrent to smartwatch data collection, subjects will be instructed to complete questionnaires via the Huma Decentralized Clinical Trials (HUMADCT) platform. There are no investigational drugs or interventions administered as part of this study.

Detailed description

The central hypothesis in the HEARTBEAT project posits that cardiovascular events are preceded by abnormalities in biometric signals obtained from a smartwatch. These abnormalities may include, but are not limited to, patterns of heart rate, heart rate variability, oxygen saturation, as well as raw PPG signals. By leveraging advanced analytics and machine learning algorithms on smartwatch-derived biometric data, the investigators plan to identify patterns and markers that signal an increased cardiovascular disease risk. The study will use an end-to-end decentralized approach for data collection. Huma and Alcedis, the electronic data capture (EDC) agencies, will act as the data storage facilitator for 10,000 eligible subjects. The Principal Investigators (PIs) and trained site staff members will assess healthy subjects based on their clinical opinion. If the subjects meet the eligibility criteria and are interested in participating, they will be consented by Tulane. During the study enrollment phase, a smartwatch will be provided to the subjects, who will then be trained on the study procedures, the web-based questionnaire, and the use of the wearable device. The subjects will be asked to wear the device for one year, after which they will return it to Tulane.

Conditions

• Heart Diseases

Interventions

Type	Name	Description
OTHER	Smartwatch	Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)

Timeline

• Start date: 2024-10-08
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2024-12-31
• Last updated: 2026-03-05

Locations

3 sites across 1 country: United States