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Life sciences · Interventional Study
ClinicalTrials.gov · October 14, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06222099). This is a study registration, not published results. Lead sponsor: Heartfelt Technologies. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Heart Failure, Chronic Heart Failure. Interventions: DEVICE: Heartfelt Device installed; OTHER: Standard care; DEVICE: Heartfelt-guided care; OTHER: Questionnaires. Primary outcome measures: 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; Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL , 12 months, plus up to 48 months long term follow-up. 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: 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.