An observational study in Heart Failure, sponsored by The Cleveland Clinic. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by The Cleveland Clinic · Observational
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.
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.
Exclusion Criteria:
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.
Time frame: 10 years
Association between Wearable-derived Heart Rate and Clinical Outcomes
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.
Time frame: 10 years
Association between Wearable-derived Physical Activity and Clinical Outcomes
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.
Time frame: 10 years
Association between Wearable-derived Sleep Metrics and Clinical Outcomes
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.
Time frame: 10 years
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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