Clinical trial NCT06222099: The HEARTFELT Study
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Heartfelt Technologies
Sponsor class: INDUSTRY
First posted: 2024-01-24
Enrollment: 1500
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This trial is a crossover randomized study with two arms:

1. Standard Care (control): Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP;
2. 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).

Optional long-term follow-up where the device will be placed in "Intervention" mode, with randomized 100-day periods of "Standard care" mode (control).
Primary purpose: PREVENTION

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).

Eligibility criteria: 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

Primary outcomes:
measure: Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL
timeFrame: 12 months, plus up to 48 months long term follow-up
Secondary outcomes:
measure: Difference in data availability (device generated or contemporaneous self-report)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: The date and length (in hours) of hospital admission and re-admissions
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Cause of hospitalizations (HF or non-HF)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Date of increase in HF medications when the patient is home or in the community (not the detailed changes whilst on the ward)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Death and cause of death from the clinical record (HF or non-HF as defined in [1-Abraham])
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Loss of independence (patient unable to live at home; for example, relocation to a care facility for an indefinite duration)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Route of admission for hospitalization events (ICU, CCU, or ward admission),and discharge (home, skilled nursing facility and long term care facility).
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Scheduling of care events (scheduled or unscheduled)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: The setting of care events (inpatient or outpatient)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Date and time of health alerts generated by the Heartfelt device
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Date, time and method of contact made following reception of a health alert generated by the Heartfelt device
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Date and reason for study withdrawal
timeFrame: 12 months, plus up to 48 months long term follow-up
Other outcomes:
measure: NT Pro-BNP or BNP, with date if available in patient records
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Date and time of health alerts from other monitoring devices
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Symptoms diary (if available)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Questionnaire responses (if available)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Dates, types and length of stays in rehab facilities/nursing home/care homes
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Dates and times of caregivers' shifts if home healthcare used
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: HFHs in the 12 months prior to installation (as defined in [1-Abraham])
timeFrame: Retrospectively, over the 12 months prior to device installation
measure: UHFV and other urgent healthcare usage in the 12 months prior to installation
timeFrame: Retrospectively, over the 12 months prior to device installation
measure: Date and cause of Death
timeFrame: 12 months
measure: Ethnicity
timeFrame: At enrollment
measure: NYHA class
timeFrame: At enrollment
measure: Ejection fraction
timeFrame: At enrollment
measure: Comorbidities
timeFrame: At enrollment
measure: Date, prescription fulfillment and any modifications to dosage of HF medications (if available)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Optimal medical therapy score (if available)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Presence of edema reported by clinicians during the clinical encounter (including grading of edema if available)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Data availability (device generated or contemporaneous self-report) in the 6 months prior to screening.
timeFrame: Retrospectively, over the 6 months prior to screening
measure: Device-related complications
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: 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)
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Tobacco consumption
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Alcohol consumption
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Cannabis consumption
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Other recreational drug(s) consumption
timeFrame: 12 months, plus up to 48 months long term follow-up
measure: Cause of hospitalizations (ICD-10-CM codes)
timeFrame: 12 months, plus up to 48 months long term follow-up
Locations:
Study officials:
affiliation: Cleveland Clinic, USA
name: WH Wilson Tang, MD
role: STUDY_CHAIR
References: