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RecruitingNCT06753045

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

Sponsor

Tulane University

Enrollment

10,000 participants

Start Date

Oct 8, 2024

Study Type

OBSERVATIONAL

Conditions

Heart Diseases

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.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This observational study uses wearable health devices to track cardiovascular health trends and risks over time in people with heart conditions, kidney disease, diabetes, or stroke history — as well as in a group of healthy individuals for comparison. **You may be eligible if...** - You have at least one of: heart failure, irregular heartbeat (arrhythmia), chronic kidney disease, coronary artery disease, history of stroke or TIA, or diabetes - OR you are generally healthy (limited spots available for a comparison group) - You are a patient at one of the participating clinics - You have a compatible smartphone (iOS 13 or Android 11 minimum) **You may NOT be eligible if...** - You cannot read, speak, or understand English - You have significant cognitive impairment - You are pregnant - You have a pacemaker - You have tattoos, scars, or skin conditions on your wrist that would block the wearable sensor - You have hand tremors or other neurological conditions affecting signal quality - You plan to permanently leave Louisiana during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSmartwatch

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

Locations(3)

East Jefferson General Hospital

New Orleans, Louisiana, United States

Tulane University Medical Group Clinics

New Orleans, Louisiana, United States

University Medical Center

New Orleans, Louisiana, United States

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NCT06753045

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