RecruitingNot Applicable

The HEARTFELT Study

United States1,500 participantsStarted 2025-10-23

Plain-language 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 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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.
. Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following:
. Patients who are treated with daily diuretics.
. Evidence of non-adherence defined by one or more of the following:

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is tracking a composite of heart failure events — including hospitalizations and worsening heart failure without hospitalization, as well as kidney function changes like doubling of creatinine — what does that mean for how closely I'd need to be monitored, and is that level of follow-up realistic given my current health situation?
2Since this trial is listed as 'Phase NA,' it doesn't follow the standard Phase 1–3 drug trial structure — can you help me understand what kind of intervention or observation is being studied here, and what that means for what's actually known about its safety and benefit so far?
3The trial is measuring kidney function decline as a key outcome — given my current creatinine levels and kidney health, is there any reason my participation could put my kidneys at additional risk, or would this trial actually help catch problems earlier?
4Given that this trial is still actively recruiting, would joining it delay or replace any standard heart failure treatments I might otherwise start now, or could I pursue both at the same time?
5If my heart failure worsens during the trial — one of the very outcomes they're tracking — what happens next: would I be able to leave the study and switch to a different treatment plan without it affecting my care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])

Timeframe: 12 months, plus up to 48 months long term follow-up

Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL

Timeframe: 12 months, plus up to 48 months long term follow-up

Trial details

NCT IDNCT06222099

SponsorHeartfelt Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

WH Wilson Tang, MD

+441223 967250 usa.trial@hftech.org

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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.
. Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following:
. Patients who are treated with daily diuretics.
. Evidence of non-adherence defined by one or more of the following:

What they're measuring

Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])

Timeframe: 12 months, plus up to 48 months long term follow-up

Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL

Timeframe: 12 months, plus up to 48 months long term follow-up