Actively Recruiting
The HEARTFELT Study
Led by Heartfelt Technologies · Updated on 2026-05-06
1500
Participants Needed
2
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The HEARTFELT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form (wet or digital signature)
- Male or female aged 22 years or older with no maximum age limit
- Diagnosed with chronic heart failure at least 2 months before randomization
- Documented history of peripheral edema in feet or lower legs
- History of heart failure decompensation or high risk of hospitalization based on hospitalizations, diuretic treatments, emergency visits, or clinician assessment within 6-12 months
- Currently treated with daily diuretics
- Evidence of non-adherence to monitoring or therapy as shown by historical monitoring data, medical record documentation, or clinical team assessment
- For females of reproductive potential, use of highly effective contraception for at least 1 month prior to screening and agreement to continue during and 6 weeks after the study
- Coverage by an insurance plan covering IDE-B costs or signed contract accepting trial-associated costs
You will not qualify if you...
- Daily bandages on lower limbs
- Amputation of both feet
- Regular wheelchair use inside the home
- Bed-bound status
- No fixed abode
- Participation in conflicting studies or evaluations
- Unable to take diuretics
- On a regular dialysis schedule
- History of recurrent deep vein thrombosis in legs or feet (2 or more episodes in last 12 months)
- History of recurrent cellulitis in legs or feet (2 or more episodes in last 12 months)
- Ongoing prescription of diltiazem or verapamil
- Pregnant or not using medically approved birth control if of child-bearing potential
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
HealthArc
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
2
Connect America
Bala-Cynwyd, Pennsylvania, United States, 19004
Actively Recruiting
Research Team
W
WH Wilson Tang, MD
CONTACT
A
Amparito Cunningham, MD. MPH.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
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