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Study identifier: NCT06222099 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

The HEARTFELT Study

Condition: Heart Failure · Chronic Heart Failure  ·  Sponsor: Heartfelt Technologies

PhaseNA
Planned participants1500
Who can joinAll sexes, 22 Years to no upper limit
Healthy volunteersNo

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.

This description comes directly from the study's public registry record.

Talk to the study team

WH Wilson Tang, MD  ·  +441223 967250  ·  usa.trial@hftech.org

Amparito Cunningham, MD. MPH.  ·  6176425062  ·  amparito@hftech.org

Always discuss trial participation with your own doctor first.

Locations (3)

Baptist HealthLittle Rock, Arkansas, United StatesActive Not Recruiting
HealthArcHackensack, New Jersey, United StatesRecruiting
Connect AmericaBala-Cynwyd, Pennsylvania, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT06222099