Clinical trial NCT06753045: Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology
Official title: Health Electronic Assessment of Risks and Trends Using Biometric Equipment and Technology: HEARTBEAT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
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
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2024-12-31
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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 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).

Primary outcomes:
measure: The incidence of cardiovascular events indicative of progression of pre-existing cardiovascular conditions
timeFrame: 1 Year
measure: The incidence of new cardiovascular diseases events
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: East Jefferson General Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Medical Group Clinics
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane University
name: Nassir Marrouche, MD
role: PRINCIPAL_INVESTIGATOR
References: