The HEARTFELT Study

Heartfelt Technologies

Status: Not yet enrolling

Conditions: Heart Failure

Treatments: Other: Questionnaires; Device: Heartfelt Device installed; Other: Standard care; Device: Heartfelt-guided care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06222099

55241

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,500 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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1,500 participants in 2 patient groups

Standard Care (control)

Active Comparator group

Description:

Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.

Treatment:

Other: Standard care

Device: Heartfelt Device installed

Other: Questionnaires

Standard Care + Heartfelt (intervention)

Experimental group

Description:

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).

Treatment:

Device: Heartfelt-guided care

Other: Standard care

Device: Heartfelt Device installed

Other: Questionnaires