Heart DiseasesHEARTBEATNCT06753045
Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
An observational study of Heart Diseases, run by Tulane University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Smartwatch
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 8 Oct 2024to Jul 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
East Jefferson General Hospital
New Orleans, Louisiana, 70006
Tulane University Medical Group Clinics
New Orleans, Louisiana, 70112
University Medical Center
New Orleans, Louisiana, 70112
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Diseases
- Being tested
- Smartwatch
- 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
- Medical subject headings
- Heart Diseases, Heart Failure, Coronary Artery Disease, Diabetes Mellitus, Renal Insufficiency, Chronic, Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartwatchOther
Sensors on the smartwatch will measure vitals such as heart rate, blood pressure, oxygen saturation, body composition, and electrocardio gram (ECG)
| Study group | Role | What they receive |
|---|---|---|
| Cohort arm | Patients with at least one cardiovascular disease, 9500 subjects. Receives: Other: Smartwatch | |
| Healthy arm | Patients visiting a primary care provider for any reason without any cardiovascular diseases, 500 subjects. Receives: Other: Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start8 Oct 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Sponsor
- Investigators
- Nassir Marrouche, MD, Principal investigator, Tulane University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06753045
- Sponsor's protocol ID
- 2024-652
- Acronym
- HEARTBEAT
- Status last verified
- Sep 2026
- First submitted
- 21 Dec 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No