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Observational Study of Smartwatches for Heart Disease Detection

This study, called HEARTBEAT, is looking at how smartwatches can help us understand and detect heart diseases better. Researchers want to see if the information collected by smartwatches, like your heart rate and blood pressure, can show early signs of heart problems. You could join if you are an adult (18-120 years old) and either have a heart condition (like heart failure or diabetes) or are visiting a primary care doctor for any reason. The study will provide you with a smartwatch to wear for one year. The main goal is to see how often people experience new or worsening heart problems during that year, and if the smartwatch data can predict these events. This is an observational study, meaning there are no experimental drugs or treatments given.

Study design
This is an observational study with a planned enrollment of 10,000 adult participants. It is designed to collect data over a one-year period using smartwatches.
What's involved
You would wear a provided smartwatch for one year and complete questionnaires using a digital platform. You will be trained on how to use the device and platform.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to track cardiovascular events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06753045

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

Recruiting
Not specifiedAges 18+Observational
Tulane University
~10,000 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:Smartwatch

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions
Measured over 1 Year
+1 more outcome measured

Conditions

Heart Diseases

Explore related trials

ArrhythmiaChronic Kidney DiseaseCoronary Artery DiseaseDiabetes MellitusHeart FailureStrokeTransient Ischemic Attack

Where it's being run

3 sites across 1 states
Louisiana3

Study leadership

  • Nassir Marrouche, MD · PRINCIPAL_INVESTIGATOR · Tulane University

Who to contact

Kunal Sameer, MD, MHA
[email protected]
504-988-3058
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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).

What this trial measures

  • The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions1 Year

    These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.

  • The incidence of new cardiovascular diseases events1 Year

    These endpoints will be collected from the electronic health records using the International Classification of Diseases Tenth Edition (ICD-10) codes, prompted by a patient survey conducted via the use of a smart phone app. The investigators will use the the patient's survey answers as a prompt to check the EMR. If in the survey a patient mentions they had a cardiovascular incidence, then the EMR data will be checked to see the reports from the ER visit to confirm the incidence and check to confirm if the patient developed a new cardiovascular disease. The number that will be reported is the total number of cardiovascular incidences in each patient over the period of 1 year.