The HEARTFELT Study
A Pragmatic, Single-blind, Randomized Crossover Trial Testing the Effectiveness of Autonomous Remote Patient Peripheral Edema Monitoring and Reporting in HEART FailurE Compared to conventionaL remoTe Patient Monitoring.
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Mentioned in the study description
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Phone or video check-ins
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Mentioned in the study description
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
The HEARTFELT Study tests whether a home device that tracks swelling in the feet and lower legs is safe and helps reduce hospital stays for heart failure. It is for adults with long-term heart failure who have trouble following home monitoring or care plans. Participants must keep the device at home for at least 1 year, possibly up to 5 years, and answer monitoring phone calls to follow their care plans.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 22 or older, sign a consent form, and have had long-term heart failure for at least 2 months before being assigned to a study group.
- Have swelling in the feet or lower legs noted in your medical record.
- Have had a heart failure hospital stay, urgent or emergency visit, or water-removing medicine through a vein or under the skin at least once in the past 6 months or twice in the past year; OR have a clinician judge you at high risk of a heart failure hospital stay in the next 6–12 months.
- Take daily diuretics, or “water pills,” to remove extra fluid.
- Have trouble following monitoring or care plans, based on device records, medical records, new study scale readings, or the study team's judgment.
- If you can become pregnant, use highly effective birth control for at least 1 month before screening, throughout the study, and for 6 weeks afterward.
- Have insurance that covers the required study costs, or a written agreement from you, your provider, or your insurer to pay costs Medicare would normally cover.
Who can't join
- Have bandages on your lower legs every day, or have had both feet removed.
- Regularly use a wheelchair inside your home, or cannot get out of bed.
- Have no fixed home.
- Take part in another study that could affect this study's results or your care.
- Cannot take water pills, or receive regular dialysis, a treatment that filters the blood.
- Have had 2 or more episodes in the past year of deep blood clots in your legs or feet, or 2 or more episodes of cellulitis, a skin infection, in those areas.
- Take diltiazem or verapamil on an ongoing basis.
- Are pregnant, or can become pregnant but do not use medically approved birth control.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
INCLUSION CRITERIA: 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: 1. Participants with ≥180 days of historical monitoring/device data available ● Failure to collect ≥50% of expected days of prescribed home physiological monitoring data (e.g. weight, blood pressure, or other clinician-recommended measurements), assessed over a continuous 180-day period; OR ● Discontinuation from a remote patient monitoring/home monitoring program due to non-adherence; OR ● Failure to adhere to a prescribed home-based therapy/monitoring intervention, supported by device usage data showing \<50% of expected days of use over a continuous 180-day period. 2. Participants without ≥180 days of historical monitoring/device data available: Evidence of non-adherence may be demonstrated by low data capture over shorter windows, defined as any of the following : ● ≤2 days of monitoring data recorded for each of the most recent 4 consecutive weeks during which any remote monitoring device was continuously available in the patient's home; OR ● ≤3 days of monitoring data recorded in any consecutive 8 week period period during which any remote monitoring device was continuously available in the patient home; AND/OR * by documented non-adherence in the medical record within the last 3 years: * Historical documentation of persistent medication and/or dietary non-adherence, defined as either a clear statement of ongoing non-adherence or ≥2 documented instances of non-adherence concerns (including dosing and/or timing, where available); OR * Historical documentation on repeated clinical assessments indicating persistent difficulty adhering to recommended self-management activities (e.g. repeated failure to follow monitoring instructions, incomplete engagement with care plan, or repeated non-attendance at scheduled reviews). 3. For participants not previously enrolled in RPM or without sufficient historical monitoring data, non-adherence will be assessed prospectively using connected scales provided at study initiation. Objective adherence metrics derived from scale usage during the initial monitoring period will be used both to characterise baseline adherence and to support predefined subgroup analyses. 4. Clinical teams/PIs discretion as patients being non-adherent. 8. 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. 9. Patients who are covered by an insurance plan that covers IDE-B costs (e.g. Medicare Part-B), OR written contract signed by the patient, or their provider or payor, stating that they will be liable for any trial-associated costs that Medicare would ordinarily cover if the patient were covered by Medicare. 1\. Participant has bandages to lower limbs every day 2. Participant has an amputation of both feet 3. Participant is a regular wheelchair user inside their home 4. Participant is bed-bound 5. Participant is of no fixed abode 6. 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 7. Participant is unable to take diuretics 8. Participant is on a regular schedule of dialysis 9. Participant has a history of recurrent leg or feet deep vein thrombosis (DVT) (two or more episodes within the last 12 months). 10\. Participant has a history of recurrent leg or feet cellulitis episodes (two or more episodes within the last 12 months). 11\. Participant is prescribed diltiazem or verapamil on an ongoing basis. 12. Participant is pregnant or is not taking medically approved birth control if of child-bearing potential.
Study sites (3)
AR
- Baptist Health · Little Rock, AR 72205More trials in Little Rock
NJ
- HealthArc · Hackensack, NJ 07601Kaitlyn Batch-Monteforte, BSN., RN. · Study contact · 201-992-5561 · kaitlyn@healtharc.ioKaitlyn Batch-Monteforte, BSN., RN. · Principal investigatorMore trials in Hackensack
PA
- Connect America · Bala-Cynwyd, PA 19004Rosemary Kennedy, PhD,RN,FAAN · Study contact · 610-715-2786 · rosemary.kennedy@connectamerica.comRosemary Kennedy, PhD,RN,FAAN · Principal investigatorMore trials in Bala-Cynwyd