NCT06753045Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1500 (actual)
- First submitted
- 21 Dec 2024
- Start date
- 8 Oct 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Tulane University
- NCT number
- NCT06753045
What you commit to
- Study type: Observational
- Participants enrolled: 1500
- From 8 Oct 2024 to the primary completion date, 31 Jul 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).
- Participants with allergies to watch and/or wristband materials.
Other
- Participants who cannot read, speak, and/or understand English.
- Participants with cognitive impairments who are unable to give informed consent or sign their HIPAA form.
- Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
- Participants who are pregnant.
- Participants with tattoos, scars, or skin adhesions that would not allow for Photoplethysmography (PPG) recordings to be collected from a wrist-worn device.
- Participants with a pacemaker.
- Participants with known plans to permanently leave the state of Louisiana within the observational period.
- Participants who have no known medical history with any of the enrolling institutions.
- Patients without a compatible smartphone (iOS 13 \& Android 11 at minimum).
Who the study is looking for
- Patients with at least one cardiovascular disease (heart failure, cardiac arrhythmias, chronic kidney disease, coronary artery disease, history of stroke/Transient Ischemic Attack (TIA), or diabetes mellitus).
- Patients visiting a primary care provider for any reason without any of the previously mentioned cardiovascular diseases. (Healthy cohort, limited up to 500 patients throughout the study).
Age in the registry: 18 years to 120 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tulane University Medical Group Clinics Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| University Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| East Jefferson General Hospital Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.