The HEARTFELT Study

Study acronym: HEARTFELT
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Jan 1, 2028
See other at-risk trials from Heartfelt Technologies

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 6 words
  2. Primary completion pushed from Dec 31, 2026 to Jan 1, 2028 Show 4 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 5 of 12 entries
    • Study description expanded, about 2 words
  3. Re-verified, no change to tracked fieldsv11
  4. Site details revised at 1 of 3 sitesv10
  5. Site details revised at 2 of 3 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 2 to 3v8
  2. Study sites: 3 to 2
    • Eligibility criteria expanded, about 406 words
    v7
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 3
    • Start date changed from estimate of Oct 31, 2025 to Oct 23, 2025
    v6
  4. Start date: Apr 1, 2025 to Oct 31, 2025v5 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Nov 30, 2026 to Dec 31, 2026
    • Study completion date: Apr 1, 2030 to Dec 31, 2030
    • Eligibility criteria shortened, about 16 words
    • Study description shortened, about 6 words
  5. Start date: Jan 1, 2025 to Apr 1, 2025v4 Show 8 more changesShow less
    • Primary endpoints: 3 to 2
    • Primary completion date: Aug 30, 2026 to Nov 30, 2026
    • Study completion date: Sep 30, 2029 to Apr 1, 2030
    • Interventions: Direct-to-patient alerts (Device), Heartfelt Device installed (Device), Questionnaires (Other), RPMC care (Device), Standard care (Other) to Heartfelt Device installed (Device), Heartfelt-guided care (Device), Questionnaires (Other), Standard care (Other)
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: 16 to 12
    • Study description shortened, about 107 words
    • Study arms: 4 to 2
  6. Start date: Sep 1, 2024 to Jan 1, 2025v3
  7. Primary endpoints: 4 to 3
    • Secondary endpoints: 11 to 16
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06222099
Lead Sponsor Heartfelt Technologies
Conditions
(from sponsor)		 Heart Failure, Chronic Heart Failure
Related terms Heart Failure
Enrollment 1,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov