Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1500 participants
INTERVENTIONAL
2025-10-23
2030-12-31
Brief Summary
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* Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs.
* Secondary objectives:
1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices.
2. Establish the effect of the Heartfelt device on HF clinical outcomes.
Participants will need to:
* Install the device in their home for at least a year and up to 4 additional years after.
* Reply to remote patient monitoring phone calls to follow the care plans.
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Detailed Description
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The study design is a crossover randomization between:
* Standard care (control), 162 days: The device is installed in the home and captures data but no health alerts are sent, and the RPMP does not receive data from the device. (Health alerts are generated and stored for review at the end of the study period to correlate with health issues which occurred during usual care).
* Standard care + Heartfelt (intervention), 162 days: The device captures data and transmits volume measurements and health alerts to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
At consent, patients get randomized to an install date over a period from 21 to 60 days following consent, subject to scheduling this at least 14 days after the most recent recorded hospital discharge at the time of consent, or the discharge from their current hospitalization if hospitalized at the time of consent.
Total study length is 366 days (days 0 to 365). There are two 21-day "washout" periods to prevent carryover between study arms. The first washout period extends from day 0-20 inclusive, and the second from day 183-203 inclusive
At the completion of both crossover arms, patients will be offered the opportunity to keep the device for as long as the study remains active (potentially up to an additional 4 years, for those patients recruited early in the study). During this long-term follow-up, the device will be placed in "Intervention" mode, with randomized 100-day periods where the device is switched into "Standard care" mode (control).
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
1. Standard Care (control): Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP;
2. Standard Care + Heartfelt (intervention): Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).
Optional long-term follow-up where the device will be placed in "Intervention" mode, with randomized 100-day periods of "Standard care" mode (control).
PREVENTION
SINGLE
The focus of blinding is the Clinical Events Committee (CEC), which will adjudicate if events recorded in the EHR/Claims data count as outcome events. There is no reason for the CEC to have access to logs of contact with patients or data measured with the Heartfelt device. Prior to EHR/Claims data-derived data being provided to the CEC, it will be cleansed of any such potentially-unblinding data. This ensures unbiased outcome assessment, with the CEC not accessing device alert data.
Study Groups
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Standard Care (control)
Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.
Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Standard care
RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
Questionnaires
Patients were presented with one or more optional questionnaires (some validated, some bespoke)
Standard Care + Heartfelt (intervention)
Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).
Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Standard care
RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
Heartfelt-guided care
Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
Questionnaires
Patients were presented with one or more optional questionnaires (some validated, some bespoke)
Interventions
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Heartfelt Device installed
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
Standard care
RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
Heartfelt-guided care
Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
Questionnaires
Patients were presented with one or more optional questionnaires (some validated, some bespoke)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female, aged 22 to \[No maximum age\]
* Diagnosed with Chronic Heart failure at least 2 months prior to randomization.
* Exhibited peripheral edema on at least one HF-related hospitalization in the last 4 years (as documented in EHR).
* Has been hospitalized for HF, received IV diuretics treatment or visited the ER for HF decompensation at least once in the last 6 months or twice in the last 12 months.
* Participants who are treated with daily diuretics.
* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.
* Has failed to collect at least 50% of days over the last 180 of physiological data (incl. home weights and/or BP) from monitoring devices OR has been discontinued from remote patient monitoring due to non-adherence, OR, is considered by clinical team as non-adherent but does not have historical physiological data from monitoring devices.
* Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare).
Exclusion Criteria
* Participant has an amputation of both feet
* Participant is a regular wheelchair user inside their home
* Participant is bed-bound
* Participant is of no fixed abode
* Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
* Participant who was unable to have the device installed and activated within 90 days of the randomized installation date
* Participant is unable to take diuretics
* Participant is on a regular schedule of dialysis
* Participant has a history of recurrent deep vein thrombosis (DVT) (two or more episodes within the last 12 months).
* Participant has a history of recurrent cellulitis episodes (two or more episodes within the last 12 months).
* Participant is prescribed diltiazem or verapamil on an ongoing basis.
* Participant is pregnant or is not taking relevant birth control if of child-bearing potential
22 Years
ALL
No
Sponsors
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Heartfelt Technologies
INDUSTRY
Responsible Party
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Principal Investigators
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WH Wilson Tang, MD
Role: STUDY_CHAIR
Cleveland Clinic, USA
Locations
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Rimidi
Atlanta, Georgia, United States
HealthArc
Hackensack, New Jersey, United States
Connect America
Bala-Cynwyd, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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55241
Identifier Type: -
Identifier Source: org_study_id
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