The HEARTFELT Study
Eligible age
22+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Heartfelt Technologies
You may qualify if…
- ✓ 1. Provision of signed and dated informed consent form (wet or digital signature)
- ✓ 2. Male or female, aged 22 to \[No maximum age\]
- ✓ 3. Diagnosed with Chronic Heart failure at least 2 months prior to randomization
- ✓ 4. 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.
- ✓ 5. 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).
- ✓ 6. Patients who are treated with daily diuretics.
- ✓ 7. Evidence of non-adherence defined by one or more of the following:
Where it's recruiting
Source: ClinicalTrials.gov · NCT06222099 · last updated 2026-06-18