Status:
RECRUITING
The HEARTFELT Study
Lead Sponsor:
Heartfelt Technologies
Conditions:
Heart Failure
Chronic Heart Failure
Eligibility:
All Genders
22+ years
Phase:
NA
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 pat...
Detailed Description
Participants will be recruited through Remote Patient Monitoring Providers (RPMPs) based in the US, using crossover randomization between standard care and Heartfelt device usage with health alerts se...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form (wet or digital signature)
- Male or female, aged 22 to \[No maximum age\]
- Diagnosed with Chronic Heart failure at least 2 months prior to randomization.
- Exhibited peripheral edema on at least one HF-related hospitalization in the last 4 years (as documented in EHR).
- Has been hospitalized for HF, received IV diuretics treatment or visited the ER for HF decompensation at least once in the last 6 months or twice in the last 12 months.
- Participants who are treated with daily diuretics.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study.
- Has failed to collect at least 50% of days over the last 180 of physiological data (incl. home weights and/or BP) from monitoring devices OR has been discontinued from remote patient monitoring due to non-adherence, OR, is considered by clinical team as non-adherent but does not have historical physiological data from monitoring devices.
- Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare).
Exclusion
- Participant has bandages to lower limbs every day
- Participant has an amputation of both feet
- Participant is a regular wheelchair user inside their home
- Participant is bed-bound
- Participant is of no fixed abode
- Participant is taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes
- Participant who was unable to have the device installed and activated within 90 days of the randomized installation date
- Participant is unable to take diuretics
- Participant is on a regular schedule of dialysis
- Participant has a history of recurrent deep vein thrombosis (DVT) (two or more episodes within the last 12 months).
- Participant has a history of recurrent cellulitis episodes (two or more episodes within the last 12 months).
- Participant is prescribed diltiazem or verapamil on an ongoing basis.
- Participant is pregnant or is not taking relevant birth control if of child-bearing potential
Key Trial Info
Start Date :
October 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06222099
Start Date
October 23 2025
End Date
December 31 2030
Last Update
November 4 2025
Active Locations (3)
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1
Rimidi
Atlanta, Georgia, United States, 30324
2
HealthArc
Hackensack, New Jersey, United States, 07601
3
Connect America
Bala-Cynwyd, Pennsylvania, United States, 19004