No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 120
Sex
Any
Study type
Observational
Participants needed
10,000 (estimated)
Sponsor
Tulane University · Other
Who this trial is looking for
This trial is looking for adults with heart diseases or those who are healthy and seeking regular checkups. Participants will wear a smartwatch for a year to track health, and complete questionnaires about their condition using a mobile app.
Are You a Good Fit for This Trial?
Rules you outNeurological disorders
You may be able to join if
I have been diagnosed with a heart disease.
I visit a doctor for health checkups and do not have heart disease.
You may not be able to join if
I cannot read or understand English.
I have cognitive impairments that affect my ability to consent.
I am pregnant.
I have skin issues that prevent wearing a smartwatch.
I have a pacemaker.
I am allergic to smartwatch materials.
I plan to leave Louisiana permanently within the study period.
I do not have a compatible smartphone.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 tho…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 …
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 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 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).
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