Heart FailureWearables-HFNCT07650669
Wearable Technology in Heart Failure Patients
An observational study of Heart Failure, run by The Cleveland Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Jun 2040
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Individuals presenting with cognitive impairments or mental incapacity that would impede their understanding of, or cooperation with, the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cleveland Clinic
Cleveland, Ohio, 44195
Valesha Province, MS, 216-636-6153, provinv@ccf.org
Jeniffer Wilcox, 216-636-6153, kirsopj@ccf.org
About this study
Official title: Integration of Wearable Technology Data in Patients With or at Risk of Heart Failure
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
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2037 (estimated)
- Study completionJun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650669
- Sponsor's protocol ID
- 26-550
- Other IDs
- IRB 26-550
- Acronym
- Wearables-HF
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Wearable Technology Data in Patients With or at Risk of Heart Failure
- ClinicalTrials.gov ID
- NCT07650669
- Acronym / sponsor ID
- Wearables-HF / 26-550
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Wearable Device, FitBit, Garmin, Apple Watch
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Case Western Reserve University
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2037 (estimated)
- Study completion
- Jun 2040 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Individuals presenting with cognitive impairments or mental incapacity that would impede their understanding of, or cooperation with, the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Association between Wearable-derived Heart Rate and Clinical Outcomes
Time frame: 10 years
Association between Wearable-derived Physical Activity and Clinical Outcomes
Time frame: 10 years
Association between Wearable-derived Sleep Metrics and Clinical Outcomes
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Related trials for Heart Failure
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valesha Province, MS (216-636-6153, provinv@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish Wearables Registry (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.