[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heartfelt Technologies\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},1500,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Heart Failure","Chronic Heart Failure",[30,31,32,33],"remote patient monitoring","chronic heart failure","heart failure","non-adherent heart failure","RECRUITING","2026-06-26",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2025-10-23",{"date":42,"type":21},"2030-12-31",{"name":44,"class":45},"Heartfelt Technologies","INDUSTRY",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100598143","monitoring-oedema-in-heart-failure-to-improve-function-and-reduce-hospitalisation-risk-100598143","NCT07067658","Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk","ME-HF","Inclusion Criteria: Participants are eligible if they meet all General Criteria and at least one of Pathways A, B, or C.\n\n1\\. General Criteria (all participants must meet)\n\n* Aged ≥18 years, AND\n* Diagnosis of heart failure (any aetiology or LVEF classification), AND\n* Documented or patient-reported moderate to severe leg oedema, AND\n* Lives in the UK with a home environment suitable for installation of the Heartfelt device\n\nPathway A: High risk patient with daily diuretics\n\n* Currently prescribed ≥40 mg\u002Fday of furosemide (or equivalent loop diuretic, eg. bumetanide or torsemide) for at least one month, AND\n* Any cardiorespiratory admission\\*\\* in the last 12 months (Includes outpatient IV diuretics, subcutaneous loop diuretics, or escalation to combination therapy with a loop diuretic and a thiazide or thiazide-like diuretic (eg: metolazone, bendroflumethiazide, indapamide etc).\n\nPathway B: High risk patient without daily diuretics\n\n* Patients prescribed SGLT2 inhibitor (eg; dapagliflozin or empagliflozin) , AND\n* Patients prescribed oral furosemide ≥40mg\u002Fday but advised to take it only as needed AND either:\n\n  a) at least two admissions\\* caused or complicated by worsening heart failure in the previous 12 months, OR b) a measurement of plasma NT-proBNP exceeding 1,000 ng\u002FL (pg\u002FmL) in the previous 12 months Pathway C: Implanted Haemodynamic Monitoring Devices (minimum n=10 participants)\n* Uses an implantable device designed to monitor congestion (e.g. CardioMEMS, HeartLogic, or equivalent)\n* Enrichment criteria: Patients must also meet a minimum total score of 4 from the characteristics below.\n\n  1. NYHA class III and IV (score: 2)\n  2. ≥80 mg\u002Fday Furosemide or equivalent loop diuretic (score: 2)\n  3. \\\u003C3 Number of times the patient has weighed themselves in the last 2 weeks (score: 2)\n  4. Help for essential daily activities required (score: 2)\n  5. GRMT score \\\u003C5 (score: 2)\n  6. Use of a walking stick, walker or mobility scooter (score: 2)\n  7. \\>2 Number of HF events in last 12 months (score: 2)\n  8. Aged over 75 (score: 1)\n  9. Health issues limiting daily activities (score: 1)\n  10. Help getting to medical appointment required (score: 1)\n  11. Problematic \u002F not tolerated uptitration of medications:\n\n      MRA (score: 1) SGLT2i (score: 1) Other (score: 1)\n  12. English as a second language (score: 1)\n  13. eGFR 20-45 (score: 1)\n  14. Patient unable to regularly attend appointments for any reason (score: 1)\n  15. \\>3 Number of co-morbidities (score: 1)\n\nExclusion Criteria:\n\n* Amputation of both feet\n* Bed-bound for more than 20h per 24h period\n* Bandages to lower limbs every day\n* Regular wheelchair user inside their home\n* No fixed abode\n* Participation in another interventional trial that may interfere with endpoints\n* Life expectancy \\\u003C6 months, in the opinion of the investigator\n* Inability to provide informed consent due to cognitive impairment\n* Language barriers that preclude understanding of trial procedures (unless translation resources are available in relevant language)\n* Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study.\n* Patients with severe aortic stenosis or awaiting a heart procedure or surgery\n* Patient with end stage renal disease (eGFR \\\u003C20)\n* Pregnancy or lack of contraceptive measures if of child-bearing potential","18 Years",{"count":56,"type":21},300,[24],"This study will evaluate the Heartfelt device, a novel, passive monitoring system that detects early signs of fluid build-up in patients (oedema) with heart failure by measuring changes in foot and lower leg volume through capture of 3D images. The trial will assess whether this device, when added to standard NHS care, improves quality of life and reduces heart failure-related events compared to standard care alone.",[27],[61,62,63],"Peripheral Oedema","Heart Failure Decomposition","Heart Failure Hospitalization","2026-05-19",{"date":66,"type":38},"2026-05-20",{"date":68,"type":38},"2025-12-18",{"date":70,"type":21},"2027-07-31",{"name":44,"class":45},18,""]