The HEARTFELT Study (HEARTFELT)

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 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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Chronic Heart Failure
• Intervention / Treatment: Device: Heartfelt Device installed; Other: Questionnaires; Other: Standard care; Device: Heartfelt-guided care

Detailed Description

Participants will be recruited through Remote Patient Monitoring Providers (RPMPs) based in the US, using crossover randomization between standard care and Heartfelt device usage with health alerts sent to RPMPs. The RPMPs will follow a protocolized intervention when responding to raised alerts.

The study design is a crossover randomization between:

• Standard care (control), 162 days: The device is installed in the home and captures data but no health alerts are sent, and the RPMP does not receive data from the device. (Health alerts are generated and stored for review at the end of the study period to correlate with health issues which occurred during usual care).
• Standard care + Heartfelt (intervention), 162 days: The device captures data and transmits volume measurements and health alerts to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.

At consent, patients get randomized to an install date over a period from 21 to 60 days following consent, subject to scheduling this at least 14 days after the most recent recorded hospital discharge at the time of consent, or the discharge from their current hospitalization if hospitalized at the time of consent.

Total study length is 366 days (days 0 to 365). There are two 21-day "washout" periods to prevent carryover between study arms. The first washout period extends from day 0-20 inclusive, and the second from day 183-203 inclusive

At the completion of both crossover arms, patients will be offered the opportunity to keep the device for as long as the study remains active (potentially up to an additional 4 years, for those patients recruited early in the study). During this long-term follow-up, the device will be placed in "Intervention" mode, with randomized 100-day periods where the device is switched into "Standard care" mode (control).

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WH Wilson Tang, MD; Phone Number: +441223 967250; Email: usa.trial@hftech.org
• Study Contact Backup: Name: Amparito Cunningham, MD. MPH.; Phone Number: 6176425062; Email: amparito@hftech.org

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Not yet recruiting
      • HealthArc
      • Contact: Kaitlyn Batch-Monteforte, BSN., RN.; Phone Number: 201-992-5561; Email: kaitlyn@healtharc.io
      • Principal Investigator: Kaitlyn Batch-Monteforte, BSN., RN.
  • Pennsylvania
    • Bala-Cynwyd, Pennsylvania, United States, 19004
      • Recruiting
      • Connect America
      • Contact: Rosemary Kennedy, PhD,RN,FAAN; Phone Number: 610-715-2786; Email: rosemary.kennedy@connectamerica.com
      • Principal Investigator: Rosemary Kennedy, PhD,RN,FAAN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care (control); Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.	Device: Heartfelt Device installed; Device installed in the patient's home and capturing foot volume data which are processed in the cloud.; Other Names: Remote patient monitoring device; Other: Questionnaires; Patients were presented with one or more optional questionnaires (some validated, some bespoke); Other Names: KCCQ, 5Q-5D, PAM Questionnaire, Bespoke Questionnaire; Other: Standard care; RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.; Other Names: Daily weighing, Breathlessness, Dizziness, Tiredness
Experimental: Standard Care + Heartfelt (intervention); Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).	Device: Heartfelt Device installed; Device installed in the patient's home and capturing foot volume data which are processed in the cloud.; Other Names: Remote patient monitoring device; Other: Questionnaires; Patients were presented with one or more optional questionnaires (some validated, some bespoke); Other Names: KCCQ, 5Q-5D, PAM Questionnaire, Bespoke Questionnaire; Other: Standard care; RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.; Other Names: Daily weighing, Breathlessness, Dizziness, Tiredness; 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 Names: Daily weighing, Remote patient monitoring

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in data availability (device generated or contemporaneous self-report)	Used to measure the data availability from the Heartfelt device. One of the key findings from feasibility trials and pilot studies in the UK have demonstrated an increased data availability. Does this study in the US confirm the previous finding?	12 months, plus up to 48 months long term follow-up
The date and length (in hours) of hospital admission and re-admissions	Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.	12 months, plus up to 48 months long term follow-up
Cause of hospitalizations (HF or non-HF)	Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.	12 months, plus up to 48 months long term follow-up
Date of increase in HF medications when the patient is home or in the community (not the detailed changes whilst on the ward)	This may include oral diuretic, IV diuretics and subcutaneous furosemide injections. Used to allow the determination if an outpatient appointment is HF related or not.	12 months, plus up to 48 months long term follow-up
Death and cause of death from the clinical record (HF or non-HF as defined in [1-Abraham])	Used to establish if using the device changes HF- or non-HF mortality.	12 months, plus up to 48 months long term follow-up
Loss of independence (patient unable to live at home; for example, relocation to a care facility for an indefinite duration)	Used to establish if there has been an effect on the ability of the patient to live independently in their home.	12 months, plus up to 48 months long term follow-up
Route of admission for hospitalization events (ICU, CCU, or ward admission),and discharge (home, skilled nursing facility and long term care facility).	Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.	12 months, plus up to 48 months long term follow-up
Scheduling of care events (scheduled or unscheduled)	Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.	12 months, plus up to 48 months long term follow-up
The setting of care events (inpatient or outpatient)	Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.	12 months, plus up to 48 months long term follow-up
Date and time of health alerts generated by the Heartfelt device	Used to establish the response time to health alerts.	12 months, plus up to 48 months long term follow-up
Date, time and method of contact made following reception of a health alert generated by the Heartfelt device	Used to establish the response time to health alerts.	12 months, plus up to 48 months long term follow-up
Date and reason for study withdrawal	Used alongside the analysis of other right-censoring endpoints.	12 months, plus up to 48 months long term follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NT Pro-BNP or BNP, with date if available in patient records	Used to correlate NT Pro-BNP health alert status.	12 months, plus up to 48 months long term follow-up
Date and time of health alerts from other monitoring devices	Used to correlate health alerts from other medical devices and the Heartfelt device.	12 months, plus up to 48 months long term follow-up
Symptoms diary (if available)	Used to establish patient usage of symptom diaries.	12 months, plus up to 48 months long term follow-up
Questionnaire responses (if available)	Used to establish patient acceptability of the device.	12 months, plus up to 48 months long term follow-up
Dates, types and length of stays in rehab facilities/nursing home/care homes	Recorded in hours if <48h and in days if >48h. Proxy used to identify trends in worsening of patient's health/independence/quality of life following participation in various arms of the study.	12 months, plus up to 48 months long term follow-up
Dates and times of caregivers' shifts if home healthcare used	Proxy used to identify trends in worsening of patient's health/independence/quality of life following participation in various arms of the study.	12 months, plus up to 48 months long term follow-up
HFHs in the 12 months prior to installation (as defined in [1-Abraham])	Used to compare HF Hospitalization date before the study as a baseline period and during the study.	Retrospectively, over the 12 months prior to device installation
UHFV and other urgent healthcare usage in the 12 months prior to installation	Used to compare Heart Failure Visit numbers before the study as a baseline period and during the study.	Retrospectively, over the 12 months prior to device installation
Date and cause of Death	Used to supplement data on HF-related death that is collected as a primary endpoint from clinical records of participants, as well as allowing the comparison to non-participants.	12 months
Ethnicity	Used to analyze the other endpoints based on this subgroup.	At enrollment
NYHA class	Used to analyze the other endpoints based on this subgroup.	At enrollment
Ejection fraction	Used to analyze the other endpoints based on this subgroup.	At enrollment
Comorbidities	Used to analyze the other endpoints based on this subgroup.	At enrollment
Date, prescription fulfillment and any modifications to dosage of HF medications (if available)	Used to get an indication of medication adherence.	12 months, plus up to 48 months long term follow-up
Optimal medical therapy score (if available)	Used to get an indication of medication adherence.	12 months, plus up to 48 months long term follow-up
Presence of edema reported by clinicians during the clinical encounter (including grading of edema if available)	Used to validate the device's determination of edema status.	12 months, plus up to 48 months long term follow-up
Data availability (device generated or contemporaneous self-report) in the 6 months prior to screening.	Used to analyze the other endpoints based on this subgroup.	Retrospectively, over the 6 months prior to screening
Device-related complications	Used to ensure that any device-related complications that occur after the main 12 months of the study are captured.	12 months, plus up to 48 months long term follow-up
Date, time, reason and means of contact made with patients by RPMPs not due to Heartfelt health alerts (e.g. phone triage/counseling, repeat labs, etc)	Used to determine if any significant changes in outcomes might be due to increases in patient contacts overall.	12 months, plus up to 48 months long term follow-up
Tobacco consumption	Used to determine if any significant changes in outcomes might be due to lifestyle choices and to analyze the other endpoints based on this subgroup.	12 months, plus up to 48 months long term follow-up
Alcohol consumption	Used to determine if any significant changes in outcomes might be due to lifestyle choices and to analyze the other endpoints based on this subgroup.	12 months, plus up to 48 months long term follow-up
Cannabis consumption	Used to determine if any significant changes in outcomes might be due to lifestyle choices and to analyze the other endpoints based on this subgroup.	12 months, plus up to 48 months long term follow-up
Other recreational drug(s) consumption	Used to determine if any significant changes in outcomes might be due to lifestyle choices and to analyze the other endpoints based on this subgroup.	12 months, plus up to 48 months long term follow-up
Cause of hospitalizations (ICD-10-CM codes)	Used to determine if a correlation could be identified between treatment effect and type of hospital stays; as well as sensitivity and specificity of the alert analysis.	12 months, plus up to 48 months long term follow-up

Collaborators and Investigators

• Sponsor: Heartfelt Technologies
• Investigators: Study Chair: WH Wilson Tang, MD, Cleveland Clinic, USA

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: heart failure; chronic heart failure; remote patient monitoring; non-adherent heart failure
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Standard of Care; Surveys and Questionnaires
• Other Study ID Numbers: 55241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Data collected for this study will be analyzed and stored by the Sponsor. After the study is completed, the de-identified, archived data will be transmitted to and stored by the Sponsor, for use by other researchers including those outside of the study. Permission to transmit data to the Sponsor will be included in the informed consent.

To further reduce the risk of patient identification, we will not associate patients with a named RPMP, we will instead use a site ID for each RPMP.

During the conduct of the study, an individual participant can choose to withdraw consent to have their de-identified data stored for future research. However, withdrawal of consent with regard to data storage may not be possible after the study is completed.

When the study is completed, access to study de-identified data will be provided through the Sponsor.

• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Contact the Sponsor
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No