The HEARTFELT Study for Chronic Heart Failure

The HEARTFELT Study is investigating a new way to monitor chronic heart failure (HF) using a device called the Heartfelt device. This device is installed in your home and measures the volume of your feet, which can indicate swelling (peripheral edema) often seen in heart failure. The study wants to see if using this device, which sends health alerts to your care team (Remote Patient Monitoring Providers or RPMPs), can help improve your care and reduce the number of times you need to be hospitalized for worsening heart failure. You might be able to join if you are 22 or older, have chronic heart failure, and a history of swelling in your feet or lower legs. The study aims to enroll 1500 participants, but its current status is unclear.

Study design: This is a pragmatic randomized crossover trial. It compares standard care with care that includes the Heartfelt device and health alerts, involving 1500 planned participants.
What's involved: You would have the Heartfelt device installed in your home. You would experience two 162-day periods: one with standard care and one with Heartfelt-guided care, with two 21-day 'washout' periods in between. You may also be asked to complete optional questionnaires.
Compensation: Not stated in the trial record.
Follow-up: Your health will be monitored for heart failure events and changes in kidney function for 12 months, with a potential long-term follow-up for up to 48 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

The HEARTFELT Study

Recruiting

NAAges 22+InterventionalPrevention

Heartfelt Technologies

~1,500 participants

Updated 2026-07-28 on ClinicalTrials.gov

What's tested:Heartfelt Device installedStandard careHeartfelt-guided careQuestionnaires

At a glance

Recruiting sites

2 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])

Measured over 12 months, plus up to 48 months long term follow-up

+1 more outcome measured

Conditions

Heart Failure

Chronic Heart Failure

Where it's being run

3 sites across 3 states

Arkansas1

New Jersey1

Pennsylvania1

Study leadership

WH Wilson Tang, MD · STUDY_CHAIR · Cleveland Clinic, USA

Who to contact

WH Wilson Tang, MD

[email protected]

+441223 967250

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

by documented non-adherence in the medical record within the last 3 years:

Historical documentation of persistent medication and/or dietary non-adherence, defined as either a clear statement of ongoing non-adherence or ≥2 documented instances of non-adherence concerns (including dosing and/or timing, where available); OR

Historical documentation on repeated clinical assessments indicating persistent difficulty adhering to recommended self-management activities (e.g. repeated failure to follow monitoring instructions, incomplete engagement with care plan, or repeated non-attendance at scheduled reviews). 3. For participants not previously enrolled in RPM or without sufficient historical monitoring data, non-adherence will be assessed prospectively using connected scales provided at study initiation. Objective adherence metrics derived from scale usage during the initial monitoring period will be used both to characterise baseline adherence and to support predefined subgroup analyses. 4. Clinical teams/PIs discretion as patients being non-adherent. 8. 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. 9. Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare Part-B), OR written contract signed by the patient, or their provider or payor, stating that they will be liable for any trial-associated costs that Medicare would ordinarily cover if the patient were covered by Medicare.

What this trial measures

Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])12 months, plus up to 48 months long term follow-up
Used to demonstrate whether the device effectively reduces HFHs and urgent HF visits.
Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL12 months, plus up to 48 months long term follow-up
Used to ensure that increased diuretic treatment following alerts from the device does not lead to significant increase in AKI

Trialytics