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RECRUITING

NCT06222099

The HEARTFELT Study

Sponsor: Heartfelt Technologies

View on ClinicalTrials.gov

Summary

This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * 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.

Official title: A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Reporting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2025-10-23

Completion Date

2030-12-31

Last Updated

2025-11-04

Healthy Volunteers

Conditions

Heart Failure Chronic Heart Failure

Interventions

DEVICE

Heartfelt Device installed

Device installed in the patient's home and capturing foot volume data which are processed in the cloud.

OTHER

Standard care

RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.

DEVICE

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.

OTHER

Questionnaires

Patients were presented with one or more optional questionnaires (some validated, some bespoke)

Inclusion Criteria: * Provision of signed and dated informed consent form (wet or digital signature) * 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 bandages to lower limbs every day * 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

Locations (3)

Rimidi

Atlanta, Georgia, United States

HealthArc

Hackensack, New Jersey, United States

Connect America

Bala-Cynwyd, Pennsylvania, United States