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.
1 other identifier
interventional
1,500
1 country
2
Brief Summary
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:
- Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices.
- Establish the effect of the Heartfelt device on HF clinical outcomes.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Oct 2025
Longer than P75 for not_applicable heart-failure
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2024
CompletedFirst Posted
Study publicly available on registry
January 24, 2024
CompletedStudy Start
First participant enrolled
October 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
May 6, 2026
May 1, 2026
1.2 years
January 4, 2024
May 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (12)
Difference in data availability (device generated or contemporaneous self-report)
12 months, plus up to 48 months long term follow-up
The date and length (in hours) of hospital admission and re-admissions
12 months, plus up to 48 months long term follow-up
Cause of hospitalizations (HF or non-HF)
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)
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])
12 months, plus up to 48 months long term follow-up
- +7 more secondary outcomes
Other Outcomes (24)
NT Pro-BNP or BNP, with date if available in patient records
12 months, plus up to 48 months long term follow-up
Date and time of health alerts from other monitoring devices
12 months, plus up to 48 months long term follow-up
Symptoms diary (if available)
12 months, plus up to 48 months long term follow-up
- +21 more other outcomes
Study Arms (2)
Standard Care (control)
ACTIVE COMPARATORDevice is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.
Standard Care + Heartfelt (intervention)
EXPERIMENTALDevice 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).
Interventions
Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
Patients were presented with one or more optional questionnaires (some validated, some bespoke)
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form (wet or digital signature)
- Male or female, aged 22 to \[No maximum age\]
- Diagnosed with Chronic Heart failure at least 2 months prior to randomization
- 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.
- 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).
- Patients who are treated with daily diuretics.
- Evidence of non-adherence defined by one or more of the following:
- 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.
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
HealthArc
Hackensack, New Jersey, 07601, United States
Connect America
Bala-Cynwyd, Pennsylvania, 19004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
WH Wilson Tang, MD
Cleveland Clinic, USA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Participants cannot be effectively blinded as they receive feedback from the RPMP in the intervention arm, and false alerts could alter the control arm's dynamics. The RPMP cannot be effectively blinded to study arms due to access to additional patient data (such as weighing scale data) to compare to any "fake" foot volume data that might be provided. The focus of blinding is the Clinical Events Committee (CEC), which will adjudicate if events recorded in the EHR/Claims data count as outcome events. There is no reason for the CEC to have access to logs of contact with patients or data measured with the Heartfelt device. Prior to EHR/Claims data-derived data being provided to the CEC, it will be cleansed of any such potentially-unblinding data. This ensures unbiased outcome assessment, with the CEC not accessing device alert data.
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2024
First Posted
January 24, 2024
Study Start
October 23, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2030
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 6 months after publication
- Access Criteria
- Contact the Sponsor
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.