The HEARTFELT Study

Conditions

• Chronic Heart Failure
• Heart Failure

Eligibility Criteria

Sex

ALL

Age

22 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Heartfelt Device installed — DEVICE
  Device installed in the patient's home and capturing foot volume data which are processed in the cloud.
• Standard care — OTHER
  RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
• Heartfelt-guided care — DEVICE
  Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
• Questionnaires — OTHER
  Patients were presented with one or more optional questionnaires (some validated, some bespoke)

Study Details

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.

Key Dates

Start date

Oct 23, 2025

Status verified

May 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2030

Study Design

Enrollment

1,500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Arms

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

Primary Outcome Measure

Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham]) [ Time Frame: 12 months, plus up to 48 months long term follow-up ]

Central Contacts

• WH Wilson Tang, MD
  +441223 967250
  [email protected]
• Amparito Cunningham, MD. MPH.
  6176425062
  [email protected]

Locations (2)

Find similar trials in Hackensack, NJ

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