Heartfelt remote edema monitoring for people with chronic heart failure

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.

This project will test whether an in-home Heartfelt device that passively detects leg swelling and sends alerts to remote care teams can help people with chronic heart failure who have trouble using other monitoring methods.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1500 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Heartfelt Technologies (industry)
• Locations: 2 sites (Hackensack, New Jersey and 1 other locations)
• Trial ID: NCT06222099 on ClinicalTrials.gov

What this trial studies

This is a pragmatic randomized crossover trial comparing standard care with a passive in-home Heartfelt device that measures peripheral edema and, during the intervention arm, transmits health alerts to remote patient monitoring providers (RPMPs) who follow a protocolized response. Each participant experiences two 162-day periods (device installed but alerts withheld versus device with alerts sent) separated by two 21-day washout windows within a 366-day total follow-up. The trial's primary objective is to determine whether the device is safe and reduces heart-failure hospitalizations, with secondary objectives to compare data availability against existing remote-monitoring approaches and to examine effects on clinical outcomes. Participants are recruited through US-based RPMPs and must have the device installed in their homes for at least one year.

Who should consider this trial

Good fit: Adults aged 22 and older with chronic heart failure (diagnosed ≥2 months), a documented history of lower-leg peripheral edema, recent decompensation or high risk for hospitalization, and who have difficulty adhering to other remote monitoring methods are the intended participants.

Not a fit: Patients without a history of peripheral edema, those with stable low-risk heart failure, individuals already adherent to effective remote monitoring, or people unable to have the device installed at home are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the device could detect worsening heart failure earlier and reduce hospitalizations by giving remote teams actionable alerts.

How similar studies have performed: Some remote monitoring programs for heart failure have shown mixed but promising reductions in hospitalizations, while passive home edema sensing like the Heartfelt device is a newer approach with limited published evidence.

Eligibility criteria

INCLUSION CRITERIA:

1. Provision of signed and dated informed consent form (wet or digital signature)
2. Male or female, aged 22 to \[No maximum age\]
3. Diagnosed with Chronic Heart failure at least 2 months prior to randomization
4. Documented history of peripheral edema (edema in feet and lower legs), defined as at least one clinical mention in the medical record indicative of oedema during prior clinical assessment.
5. Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following:

   a.Hospitalization for heart failure occurring at least once in the past 6 months or at least twice in the past 12 months; OR b.Receipt of intravenous/subcutaneous diuretic therapy for heart failure (inpatient or outpatient setting) occurring at least once in the past 6 months or at least twice in the past 12 months; OR c.Emergency department or urgent care visit for heart failure decompensation, occurring at least once in the past 6 months or at least twice in the past 12 months; OR d.Clinician assessment that the participant is at high risk of heart failure hospitalization within the next 6-12 months, based on documented recent clinical course (e.g. worsening congestion, escalating diuretic requirements, recurrent decompensation, and/or comorbidity burden).
6. Patients who are treated with daily diuretics.
7. Evidence of non-adherence defined by one or more of the following:

   1. Participants with ≥180 days of historical monitoring/device data available

      ● Failure to collect ≥50% of expected days of prescribed home physiological monitoring data (e.g. weight, blood pressure, or other clinician-recommended measurements), assessed over a continuous 180-day period; OR

      ● Discontinuation from a remote patient monitoring/home monitoring program due to non-adherence; OR

      ● Failure to adhere to a prescribed home-based therapy/monitoring intervention, supported by device usage data showing \<50% of expected days of use over a continuous 180-day period.
   2. Participants without ≥180 days of historical monitoring/device data available: Evidence of non-adherence may be demonstrated by low data capture over shorter windows, defined as any of the following :

      ● ≤2 days of monitoring data recorded for each of the most recent 4 consecutive weeks during which any remote monitoring device was continuously available in the patient's home; OR

      ● ≤3 days of monitoring data recorded in any consecutive 8 week period period during which any remote monitoring device was continuously available in the patient home; AND/OR
      * 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.

1\. Participant has bandages to lower limbs every day 2. Participant has an amputation of both feet 3. Participant is a regular wheelchair user inside their home 4. Participant is bed-bound 5. Participant is of no fixed abode 6. 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 7. Participant is unable to take diuretics 8. Participant is on a regular schedule of dialysis 9. Participant has a history of recurrent leg or feet deep vein thrombosis (DVT) (two or more episodes within the last 12 months).

10\. Participant has a history of recurrent leg or feet cellulitis episodes (two or more episodes within the last 12 months).

11\. Participant is prescribed diltiazem or verapamil on an ongoing basis. 12. Participant is pregnant or is not taking medically approved birth control if of child-bearing potential.

Where this trial is running

Hackensack, New Jersey and 1 other locations

• HealthArc — Hackensack, New Jersey, United States (NOT_YET_RECRUITING)
• Connect America — Bala-Cynwyd, Pennsylvania, United States (RECRUITING)

Study contacts

• Study coordinator: WH Wilson Tang, MD

Conditions: Heart Failure, Chronic Heart Failure, remote patient monitoring, chronic heart failure, heart failure, non-adherent heart failure