Wearable Technology in Heart Failure Patients

NCT07650669 | Recruiting

• 2 other identifiers: 26-550IRB 26-550
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to establish a Cleveland Clinic-led registry designed to integrate continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University (CWRU)-based platform, with clinical data from patients' individual Electronic Health Record (EHR). This proposal is for understanding the use of personal wearable devices (such as: Fitbit, and Apple Watch) to gather physiological data (such as: heart-rate, steps taken, sleep cycles, and calories expended) and correlate those data with self-reported health status. The research team intends to collect all of the data generated by the participant's personal wearable devices and to perform an integrated analysis of the physiological data generated by the wearable devices. The investigators specifically aim to uncover patterns from the data that they can evolve models from. The investigators' goal is to better predict and diagnose the adverse effects associated with daily lifestyle, including cardiovascular risk, musculoskeletal, metabolic risks, stress, and sleep disturbances. These data may be used to better understand the daily habits and lifestyle choices to possibly predict a person's health and disease risk to provide a more comprehensive diagnosis with early recognition and prevention. As wearable devices become more accurate and cheaper to purchase for the general public, integrative analysis of wearable data from multiple devices may lead to models that can be used by clinicians and basic scientists to make inferences about the daily lifestyle and its effects on health and disease.

Conditions

Heart Failure

Keywords

Heart Failure; Wearable Device; FitBit; Garmin; Apple Watch

Outcome Measures

Primary Outcomes (1)

• Establish Wearables Registry

  To establish a Cleveland Clinic-led registry that integrates continuous physiological data from consumer wearables, captured by the HeartBit app and a Case Western Reserve University-based platform, with comprehensive clinical and laboratory data from the Cleveland Clinic EHR.

  10 years

Secondary Outcomes (3)

• Association between Wearable-derived Heart Rate and Clinical Outcomes

  10 years

• Association between Wearable-derived Physical Activity and Clinical Outcomes

  10 years

• Association between Wearable-derived Sleep Metrics and Clinical Outcomes

  10 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective, observational registry will enroll adult participants, aged 18 to 85 years, who have been diagnosed with heart failure or are identified as being at risk of developing heart failure. The study aims to enroll an indefinite number of participants at Cleveland Clinic.

You may qualify if:

• Participants must be between 18 and 85 years of age.
• Participants must have a diagnosis of heart failure or be identified as at risk of developing heart failure.
• Participants must either own or be willing to acquire a compatible personal consumer-grade wearable device (such as Fitbit and Apple Watch) and must enroll via the HeartBit app.

You may not qualify if:

• Individuals presenting with cognitive impairments or mental incapacity that would impede their understanding of, or cooperation with, the study protocol.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Valesha Province, MS

CONTACT

216-636-6153; provinv@ccf.org

Jennifer Wilcox

CONTACT

216-636-6153; kirsopj@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, HBKR, Cleveland Clinic Research & Staff, Heart Failure, Cardiovascular Medicine

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2036
• Study Completion (Estimated): June 1, 2040
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)