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NCT Number: NCT07650669

Wearable Technology in Heart Failure Patients

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.

Recruiting

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Establish Wearables Registry

    Time frame: 10 years

    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.

Secondary outcomes

  1. Association between Wearable-derived Heart Rate and Clinical Outcomes

    Time frame: 10 years

    To determine whether, and to what extent, changes in wearable-derived heart rate are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.

  2. Association between Wearable-derived Physical Activity and Clinical Outcomes

    Time frame: 10 years

    To determine whether, and to what extent, changes in wearable-derived physical activity are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.

  3. Association between Wearable-derived Sleep Metrics and Clinical Outcomes

    Time frame: 10 years

    To determine whether, and to what extent, changes in wearable-derived sleep metrics are associated with clinical outcomes, including hospitalizations, emergency department visits, and changes in laboratory markers.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Wilcox

CONTACT

[email protected]

216-636-6153

Valesha Province, MS

CONTACT

[email protected]

216-636-6153

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Integration of Wearable Technology Data in Patients With or at Risk of Heart Failure

Acronym: Wearables-HF

Important dates

Study start
2026
Primary completion
2036
Study completion
2040
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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