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The HEARTFELT Study

NCT06222099 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2026-05-06

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Heartfelt Technologies

    lead INDUSTRY

Principal Investigators

  • WH Wilson Tang, MD · Cleveland Clinic, USA

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-23
Primary Completion
2026-12-31
Completion
2030-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06222099 on ClinicalTrials.gov