Actively Recruiting
Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
Led by Tulane University · Updated on 2026-03-05
10000
Participants Needed
3
Research Sites
155 weeks
Total Duration
On this page
Sponsors
T
Tulane University
Lead Sponsor
S
Samsung Electronics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
You will not qualify if you...
- Participants who cannot read, speak, and/or understand English.
- Participants with cognitive impairments unable to give informed consent or sign HIPAA form.
- Participants with cognitive impairments affecting compliance with wearing and maintaining wearable devices.
- Participants who are pregnant.
- Participants with tattoos, scars, or skin adhesions preventing Photoplethysmography (PPG) recordings from wrist-worn device.
- Participants with neurological disorders that may interfere with device signal quality (e.g., hand tremors).
- Participants with a pacemaker.
- Participants with allergies to watch and/or wristband materials.
- Participants with known plans to permanently leave Louisiana within the observational period.
- Participants who have no known medical history with any enrolling institutions.
- Patients without a compatible smartphone (iOS 13 & Android 11 minimum).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
East Jefferson General Hospital
New Orleans, Louisiana, United States, 70006
Actively Recruiting
2
Tulane University Medical Group Clinics
New Orleans, Louisiana, United States, 70112
Actively Recruiting
3
University Medical Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
Research Team
K
Kunal Sameer, MD, MHA
CONTACT
P
Page E McKenzie, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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