10000 Participants Needed

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

(HEARTBEAT Trial)

Recruiting at 2 trial locations
QJ
KS
Overseen ByKunal Sameer, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Tulane University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

NM

Nassir Marrouche, MD

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a heart or blood vessel condition, kidney disease, or diabetes.
I am seeing my doctor but do not have heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Training

Participants are provided with a smartwatch and trained on study procedures, including the use of the wearable device and completion of web-based questionnaires

1-2 weeks

Data Collection

Participants wear the smartwatch to collect digital biomarker data and complete questionnaires via the HUMADCT platform

1 year

Follow-up

Participants return the smartwatch and data is analyzed for patterns indicating cardiovascular risk

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Healthy armExperimental Treatment1 Intervention
Patients visiting a primary care provider for any reason without any cardiovascular diseases, 500 subjects.
Group II: Cohort armExperimental Treatment1 Intervention
Patients with at least one cardiovascular disease, 9500 subjects.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials
129
Recruited
259,000+

Samsung Electronics

Industry Sponsor

Trials
24
Recruited
12,300+
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