[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533152":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":49,"centralContacts":54,"locations":64,"responsibleParty":121,"collaborators":58,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":125,"sex":131,"minAge":132,"maxAge":58,"enrollmentInfo":133,"targetDuration":58,"studyType":136,"phases":137,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":67,"whyStopped":58,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Heartfelt Technologies","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Care (control)","ACTIVE_COMPARATOR","Device is installed and data is captured but volume measurements and health alerts are not transmitted to the RPMP.",[13,14,15],"Device: Heartfelt Device installed","Other: Standard care","Other: Questionnaires",{"label":17,"type":18,"description":19,"interventionNames":20},"Standard Care + Heartfelt (intervention)","EXPERIMENTAL","Device is installed and data is captured, and volume measurements and health alerts are transmitted to the RPMP for review and potential follow-up (per a pre-specified alert protocol).",[13,14,21,15],"Device: Heartfelt-guided care",[23,30,37,43],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Heartfelt Device installed","Device installed in the patient's home and capturing foot volume data which are processed in the cloud.",[9,17],[29],"Remote patient monitoring device",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"OTHER","Standard care","RPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.",[9,17],[36],"Daily weighing, Breathlessness, Dizziness, Tiredness",{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Heartfelt-guided care","Volume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.",[17],[42],"Daily weighing, Remote patient monitoring",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Questionnaires","Patients were presented with one or more optional questionnaires (some validated, some bespoke)",[9,17],[48],"KCCQ, 5Q-5D, PAM Questionnaire, Bespoke Questionnaire",[50],{"name":51,"affiliation":52,"role":53},"WH Wilson Tang, MD","Cleveland Clinic, USA","STUDY_CHAIR",[55,60],{"name":51,"role":56,"phone":57,"phoneExt":58,"email":59},"CONTACT","+441223 967250",null,"usa.trial@hftech.org",{"name":61,"role":56,"phone":62,"phoneExt":58,"email":63},"Amparito Cunningham, MD. MPH.","6176425062","amparito@hftech.org",[65,89,105],{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Baptist Health","RECRUITING","Little Rock","Arkansas","72205","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-92.28959,34.74648,{"lat":77,"lon":76},[80,84,86],{"name":81,"role":56,"phone":82,"phoneExt":58,"email":83},"Leah Dawson, PhD,PMP,CCRP","501-202-1301","leah.dawson@baptist-health.org",{"name":85,"role":56,"phone":58,"phoneExt":58,"email":58},"Amanda Novack",{"name":87,"role":88,"phone":58,"phoneExt":58,"email":58},"Amanda Novack, MD","PRINCIPAL_INVESTIGATOR",{"facility":90,"status":67,"city":91,"state":92,"zip":93,"country":71,"countryCode":72,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"HealthArc","Hackensack","New Jersey","07601",{"type":74,"coordinates":95},[96,97],-74.04347,40.88593,{"lat":97,"lon":96},[100,104],{"name":101,"role":56,"phone":102,"phoneExt":58,"email":103},"Kaitlyn Batch-Monteforte, BSN., RN.","201-992-5561","kaitlyn@healtharc.io",{"name":101,"role":88,"phone":58,"phoneExt":58,"email":58},{"facility":106,"status":67,"city":107,"state":108,"zip":109,"country":71,"countryCode":72,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Connect America","Bala-Cynwyd","Pennsylvania","19004",{"type":74,"coordinates":111},[112,113],-75.23407,40.00761,{"lat":113,"lon":112},[116,120],{"name":117,"role":56,"phone":118,"phoneExt":58,"email":119},"Rosemary Kennedy, PhD,RN,FAAN","610-715-2786","rosemary.kennedy@connectamerica.com",{"name":117,"role":88,"phone":58,"phoneExt":58,"email":58},{"type":122,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR","100533152","the-heartfelt-study-100533152",false,"NCT06222099","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.","HEARTFELT","INCLUSION CRITERIA:\n\n1. Provision of signed and dated informed consent form (wet or digital signature)\n2. Male or female, aged 22 to \\[No maximum age\\]\n3. Diagnosed with Chronic Heart failure at least 2 months prior to randomization\n4. 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.\n5. Evidence of heart failure decompensation or elevated risk of future hospitalization, defined by one or more of the following:\n\n   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\u002Fsubcutaneous 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\u002For comorbidity burden).\n6. Patients who are treated with daily diuretics.\n7. Evidence of non-adherence defined by one or more of the following:\n\n   1. Participants with ≥180 days of historical monitoring\u002Fdevice data available\n\n      ● 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\n\n      ● Discontinuation from a remote patient monitoring\u002Fhome monitoring program due to non-adherence; OR\n\n      ● Failure to adhere to a prescribed home-based therapy\u002Fmonitoring intervention, supported by device usage data showing \\\u003C50% of expected days of use over a continuous 180-day period.\n   2. Participants without ≥180 days of historical monitoring\u002Fdevice data available: Evidence of non-adherence may be demonstrated by low data capture over shorter windows, defined as any of the following :\n\n      ● ≤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\n\n      ● ≤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\u002FOR\n      * by documented non-adherence in the medical record within the last 3 years:\n\n        * Historical documentation of persistent medication and\u002For dietary non-adherence, defined as either a clear statement of ongoing non-adherence or ≥2 documented instances of non-adherence concerns (including dosing and\u002For timing, where available); OR\n        * 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).\n   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.\n   4. Clinical teams\u002FPIs discretion as patients being non-adherent.\n8. 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.\n9. 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.\n\n1\\. 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\u002Fstudy that could confound the results of this evaluation and\u002For 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).\n\n10\\. Participant has a history of recurrent leg or feet cellulitis episodes (two or more episodes within the last 12 months).\n\n11\\. 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.","ALL","22 Years",{"count":134,"type":135},1500,"ESTIMATED","INTERVENTIONAL",[138],"NA","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:\n\n* Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs.\n* Secondary objectives:\n\n  1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices.\n  2. Establish the effect of the Heartfelt device on HF clinical outcomes.\n\nParticipants will need to:\n\n* Install the device in their home for at least a year and up to 4 additional years after.\n* Reply to remote patient monitoring phone calls to follow the care plans.",[141,142],"Heart Failure","Chronic Heart Failure",[144,145,146,147],"remote patient monitoring","chronic heart failure","heart failure","non-adherent heart failure","2026-06-26",{"date":150,"type":151},"2026-06-29","ACTUAL",{"date":153,"type":151},"2025-10-23",{"date":155,"type":135},"2030-12-31",{"name":5,"class":6},3]