Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology (HEARTBEAT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Diseases
• Intervention / Treatment: Other: Smartwatch

Detailed Description

The central hypothesis in the HEARTBEAT project posits that cardiovascular events are preceded by abnormalities in biometric signals obtained from a smartwatch. These abnormalities may include, but are not limited to, patterns of heart rate, heart rate variability, oxygen saturation, as well as raw PPG signals. By leveraging advanced analytics and machine learning algorithms on smartwatch-derived biometric data, the investigators plan to identify patterns and markers that signal an increased cardiovascular disease risk.

The study will use an end-to-end decentralized approach for data collection. Huma and Alcedis, the electronic data capture (EDC) agencies, will act as the data storage facilitator for 10,000 eligible subjects. The Principal Investigators (PIs) and trained site staff members will assess healthy subjects based on their clinical opinion. If the subjects meet the eligibility criteria and are interested in participating, they will be consented by Tulane.

During the study enrollment phase, a smartwatch will be provided to the subjects, who will then be trained on the study procedures, the web-based questionnaire, and the use of the wearable device. The subjects will be asked to wear the device for one year, after which they will return it to Tulane.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Kunal Sameer, MD, MHA; Phone Number: 504-988-3058; Email: heartbeat@tulane.edu
• Study Contact Backup: Name: Page E McKenzie, MS; Phone Number: 504-988-3058; Email: pmckenzie@tulane.edu

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • University Medical Center
      • Principal Investigator: Nassir Marrouche, MD
      • Contact: Kunal Sameer, MD, MHA; Phone Number: 504-988-3058; Email: heartbeat@tulane.edu
      • Contact: Page E McKenzie, MS; Phone Number: 504-988-3058; Email: pmckenzie@tulane.edu
    • New Orleans, Louisiana, United States, 70006
      • Recruiting
      • East Jefferson General Hospital
      • Principal Investigator: Nassir Marrouche, MD
      • Contact: Kunal Sameer, MD, MHA; Phone Number: 504-988-3058; Email: heartbeat@tulane.edu
      • Contact: Page E McKenzie, MS; Phone Number: 504-988-3058; Email: pmckenzie@tulane.edu
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University Medical Group Clinics
      • Principal Investigator: Nassir Marrouche, MD
      • Contact: Kunal Sameer, MD, MHA; Phone Number: 504-988-3058; Email: heartbeat@tulane.edu
      • Contact: Page E McKenzie, MS; Phone Number: 504-988-3058; Email: pmckenzie@tulane.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

This study will include 10,000 patients older than 18 years who will either be healthy or with a pre-existing heart condition.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort arm; Patients with at least one cardiovascular disease, 9500 subjects.	Other: Smartwatch; Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)
Healthy arm; Patients visiting a primary care provider for any reason without any cardiovascular diseases, 500 subjects.	Other: Smartwatch; Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions	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.	1 Year
The incidence of new cardiovascular diseases events	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.	1 Year

Collaborators and Investigators

• Sponsor: Tulane University
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Nassir Marrouche, MD, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Coronary artery disease; Atrial fibrillation; Heart failure; Chronic kidney disease; Diabetes mellitus; Artificial intelligence; Machine learning; Cardiac arrhythmias; Smart watch; A-fib; Stroke/TIA
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Heart Failure; Heart Diseases; Diabetes Mellitus; Atrial Fibrillation; Coronary Artery Disease; Renal Insufficiency, Chronic; Arrhythmias, Cardiac
• Other Study ID Numbers: 2024-652

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No