Recruiting

Observational Study

Sponsor:

Tulane University

Code:

NCT06753045

Conditions

Heart Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Smartwatch

Study Details

Brief 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.

Conditions

Heart Diseases

Study ID

NCT06753045

Start date

Oct 8, 2024

Status verified date

Mar, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Cohort arm

Patients with at least one cardiovascular disease, 9500 subjects.

Healthy arm

Patients visiting a primary care provider for any reason without any cardiovascular diseases, 500 subjects.

Interventions

Smartwatch

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

Primary outcome measure

  • The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions [ Time Frame: 1 Year ]
  • The incidence of new cardiovascular diseases events [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Kunal Sameer, MD, MHA

504-988-3058heartbeat@tulane.edu

Page E McKenzie, MS

504-988-3058pmckenzie@tulane.edu

Locations

East Jefferson General Hospital

Recruiting

New Orleans, Louisiana, United States, 70006

Contacts

Kunal Sameer, MD, MHA

504-988-3058heartbeat@tulane.edu

Page E McKenzie, MS

504-988-3058pmckenzie@tulane.edu

Principal Investigator:

Nassir Marrouche, MD

Tulane University Medical Group Clinics

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Kunal Sameer, MD, MHA

504-988-3058heartbeat@tulane.edu

Page E McKenzie, MS

504-988-3058pmckenzie@tulane.edu

Principal Investigator:

Nassir Marrouche, MD

University Medical Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Kunal Sameer, MD, MHA

504-988-3058heartbeat@tulane.edu

Page E McKenzie, MS

504-988-3058pmckenzie@tulane.edu

Principal Investigator:

Nassir Marrouche, MD

More Information

Sponsor

Tulane University

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • Heart failure
  • Coronary artery disease
  • Stroke/TIA
  • Diabetes mellitus
  • Chronic kidney disease
  • Cardiac arrhythmias
  • Smart watch
  • Atrial fibrillation
  • A-fib
  • Artificial intelligence
  • Machine learning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2026-03-05.