RecruitingNot ApplicableNCT06222099

The HEARTFELT Study

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.


Sponsor

Heartfelt Technologies

Enrollment

1,500 participants

Start Date

Oct 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a smart wearable device (measuring ankle swelling) to help people with chronic heart failure better manage fluid buildup and reduce hospitalizations. **You may be eligible if...** - You are 22 or older with a diagnosis of chronic heart failure for at least 2 months - You have had leg swelling (edema) during at least one heart failure hospitalization in the past 4 years - You have been hospitalized or treated urgently for heart failure at least once in the past 6 months - You are on daily diuretic (water pill) medication - You have not consistently provided at-home monitoring data (like daily weights or blood pressure) in the past 180 days - You have insurance that covers the device cost (e.g., Medicare) **You may NOT be eligible if...** - You wear bandages on your legs daily, have had both feet amputated, or are a full-time wheelchair user or bed-bound - You do not have a fixed home address - You have received a recent heart transplant or have certain implanted devices that would interfere Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHeartfelt Device installed

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

OTHERStandard care

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

DEVICEHeartfelt-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.

OTHERQuestionnaires

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


Locations(3)

Rimidi

Atlanta, Georgia, United States

HealthArc

Hackensack, New Jersey, United States

Connect America

Bala-Cynwyd, Pennsylvania, United States

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NCT06222099


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