The HEARTFELT Study

Not Applicable

Not yet recruiting

• Conditions: Heart Failure
• Interventions: Device: Heartfelt Device installed; Device: Direct-to-patient alerts; Other: Standard care; Device: RPMC care; Other: Questionnaires

• Registration Number: NCT06222099
• Lead Sponsor: Heartfelt Technologies

Brief Summary

This study 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).

Patients 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.

Detailed Description

The hypothesis for this study is that the Heartfelt device can reliably capture foot volume data in patients' homes and that this data can be used to monitor patients remotely, ultimately reducing the risk of HF hospitalization.

This is the pivotal trial for the device in the USA.

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 Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-14
• Study Start: 2025-04-01
• Primary Completion: 2026-11-30
• Study Completion: 2030-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Provision of signed and dated informed consent form (e-consent via website or app is acceptable)
• Male or female, aged 22 to [No maximum age]
• Diagnosed with Chronic Heart failure
• Exhibited peripheral edema on at least one HF-related hospitalization in the last 4 years (as documented in EHR).
• Has been hospitalized for HF, received IV diuretics treatment or visited the ER for HF decompensation at least once in the last 6 months or twice in the last 12 months.
• Patients who are treated with daily diuretics.
• 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.
• Has failed to collect at least 50% of days over the last 180 of physiological data (incl. home weights and/or BP) from monitoring devices (targeting 80% to 85% of all patients participating), OR has been discontinued from remote patient monitoring due to non-adherence (included in the 80-85%), OR, is considered by clinical team as non-adherent but does not have historical physiological data from monitoring devices (targeting 15% to 20% of all patients participating).
• Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare).

Exclusion Criteria

• Participant has bandages to lower limbs every day
• Participant has an amputation of both feet
• Participant is a regular wheelchair user inside their home
• Participant is bed-bound
• Participant is of no fixed abode
• 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
• Participant who was unable to have the device installed and activated within 90 days of the randomized installation date
• Participant is unable to take diuretics
• Participant is on a regular schedule of dialysis
• Participant has a history of recurrent deep vein thrombosis (DVT) (two or more episodes within the last 12 months).
• Participant has a history of recurrent cellulitis episodes (two or more episodes within the last 12 months).
• Participant is prescribed diltiazem or verapamil on an ongoing basis.
• Participant is pregnant or is not taking relevant birth control if of child-bearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Care (Control)	Heartfelt Device installed	Device installed at home, capturing data without sending health alerts or measurement data to RPMC.
Direct-to-patient health alerts	Direct-to-patient alerts	Device provides direct health alerts to patients/family, but does not transmit measurement data to RPMC.
Standard Care (Control)	Standard care	Device installed at home, capturing data without sending health alerts or measurement data to RPMC.
Standard Care (Control)	Questionnaires	Device installed at home, capturing data without sending health alerts or measurement data to RPMC.
Direct-to-patient health alerts	Heartfelt Device installed	Device provides direct health alerts to patients/family, but does not transmit measurement data to RPMC.
RPMC Care Only	RPMC care	Device transmits measurement data to RPMC without direct patient alerts.
RPMC + Direct-to-Patient Health Alerts	Direct-to-patient alerts	Device sends measurement data to RPMC and provides direct alerts to patients/family.
Direct-to-patient health alerts	Questionnaires	Device provides direct health alerts to patients/family, but does not transmit measurement data to RPMC.
RPMC Care Only	Heartfelt Device installed	Device transmits measurement data to RPMC without direct patient alerts.
RPMC Care Only	Questionnaires	Device transmits measurement data to RPMC without direct patient alerts.
RPMC + Direct-to-Patient Health Alerts	Heartfelt Device installed	Device sends measurement data to RPMC and provides direct alerts to patients/family.
RPMC + Direct-to-Patient Health Alerts	RPMC care	Device sends measurement data to RPMC and provides direct alerts to patients/family.

Primary Outcome Measures

Name	Time	Method
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/dL	12 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

Secondary Outcome Measures

Name	Time	Method
Difference in data availability (device generated or contemporaneous self-report)	12 months, plus up to 48 months long term follow-up	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?
The date and length (in hours) of hospital admission and re-admissions	12 months, plus up to 48 months long term follow-up	Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.
Cause of hospitalizations (HF or non-HF)	12 months, plus up to 48 months long term follow-up	Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.
Date of increase in HF medications when the patient is home or in the community (not the detailed changes whilst on the ward)	12 months, plus up to 48 months long term follow-up	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.
Death and cause of death from the clinical record (HF or non-HF as defined in [1-Abraham])	12 months, plus up to 48 months long term follow-up	Used to establish if using the device changes HF- or non-HF mortality.
Loss of independence (patient unable to live at home; for example, relocation to a care facility for an indefinite duration)	12 months, plus up to 48 months long term follow-up	Used to establish if there has been an effect on the ability of the patient to live independently in their home.
Route of admission for hospitalization events (ICU, CCU, or ward admission),and discharge (home, skilled nursing facility and long term care facility).	12 months, plus up to 48 months long term follow-up	Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.
Scheduling of care events (scheduled or unscheduled)	12 months, plus up to 48 months long term follow-up	Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.
The setting of care events (inpatient or outpatient)	12 months, plus up to 48 months long term follow-up	Used to establish if using the device changes the scheduling and/or setting of care and/or route of admission.
Date and time of health alerts generated by the Heartfelt device	12 months, plus up to 48 months long term follow-up	Used to establish the response time to health alerts.
Date, time and method of contact made following reception of a health alert generated by the Heartfelt device	12 months, plus up to 48 months long term follow-up	Used to establish the response time to health alerts.
Date and reason for study withdrawal	12 months, plus up to 48 months long term follow-up	Used alongside the analysis of other right-censoring endpoints.