[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598143":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":53,"centralContacts":54,"locations":60,"responsibleParty":345,"collaborators":347,"id":352,"slug":353,"hasResults":354,"nctId":355,"briefTitle":356,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":354,"sex":359,"minAge":360,"maxAge":53,"enrollmentInfo":361,"targetDuration":53,"studyType":364,"phases":365,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":63,"whyStopped":53,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},{"fullName":5,"class":6},"Heartfelt Technologies","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Enhanced Standard Care + Heartfelt Device","EXPERIMENTAL","Heartfelt device's camera-based system passively measures foot and leg swelling each day as participants walk past it. Patients in this experimental control arm will not receive health alerts from the Heartfelt device, though data will still be passively collected.\n\nPatients will also be provided with the British Heart Foundation patient booklet to improve their understanding and self-monitoring of the disease.",[13,14,15,16],"Device: Installation of Heartfelt Device","Other: Enhanced Standard care","Other: Questionnaires","Device: Heartfelt device alerting system",{"label":18,"type":19,"description":20,"interventionNames":21},"Enhanced Standard Care (Control)","ACTIVE_COMPARATOR","In addition to standard care activities, participants have the Heartfelt device at home. During this arm, data is captured without sending health alerts or measurement data to the patient, carers and clinicians.\n\nPatients will also be provided with the British Heart Foundation patient booklet to improve their understanding and self-monitoring of the disease.",[13,14,15],[23,30,40,47],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Installation of Heartfelt Device","Device installed in the patient's home and capturing foot volume data which are processed in the cloud.",[18,9],[29],"Remote Patient Monitoring Device",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"OTHER","Enhanced Standard care","Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation. At the start of the study, they will be reminded (or told) about the importance of self-checks and will be handed a patient booklet (from the British Heart Foundation) to standardise patients' knowledge.",[18,9],[36,37,38,39],"Daily Weighing","Breathlessness","Dizziness","Tiredness",{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Questionnaires","Patients are presented with one or more optional questionnaires (some validated, some bespoke)",[18,9],[45,46],"5Q-5D","Bespoke Questionnaires",{"type":24,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Heartfelt device alerting system","The Heartfelt device sends alerts on the active comparator arm to the patients directly (audio-visual alert on the device, and app alerts), carers and\u002For medical professionals.",[9],[52],"Remote patient monitoring device",null,[55],{"name":56,"role":57,"phone":58,"phoneExt":53,"email":59},"Oriane Chausiaux","CONTACT","01223967250","me-hf.trial@hftech.org",[61,82,98,114,130,146,162,177,193,210,224,240,256,271,286,301,315,330],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Buckinghamshire Healthcare NHS Trust","RECRUITING","Aylesbury","Buckinghamshire","HP21 8AL","United Kingdom","UK",{"type":70,"coordinates":71},"Point",[72,73],-0.81458,51.81665,{"lat":73,"lon":72},[76,79],{"name":77,"role":57,"phone":78,"phoneExt":53,"email":59},"James Cooper","01296 831378",{"name":80,"role":81,"phone":53,"phoneExt":53,"email":53},"Nicola Bowers","PRINCIPAL_INVESTIGATOR",{"facility":83,"status":63,"city":84,"state":85,"zip":86,"country":67,"countryCode":68,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Croydon Health Services NHS Trust","Croydon","Greater London","CR7 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Health","Patrington","Hull","HU120PH",{"type":70,"coordinates":120},[121,122],-0.0133,53.68395,{"lat":122,"lon":121},[125,128],{"name":126,"role":57,"phone":127,"phoneExt":53,"email":59},"Joanne Kelly","01482899111",{"name":129,"role":81,"phone":53,"phoneExt":53,"email":53},"Thobile Nkomo, Dr",{"facility":131,"status":63,"city":132,"state":133,"zip":134,"country":67,"countryCode":68,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Kent Community Health NHS Foundation Trust","Ashford","Kent","TN25 4AZ",{"type":70,"coordinates":136},[137,138],0.87376,51.14648,{"lat":138,"lon":137},[141,144],{"name":142,"role":57,"phone":143,"phoneExt":53,"email":59},"Charlotte Marlow","01987252381",{"name":145,"role":81,"phone":53,"phoneExt":53,"email":53},"Jacqueline Sinnott",{"facility":147,"status":63,"city":148,"state":149,"zip":150,"country":67,"countryCode":68,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Lincolnshire Community Health Services NHS Trust","Lincoln","Lincolnshire","LN5 7JH",{"type":70,"coordinates":152},[153,154],-0.53792,53.22683,{"lat":154,"lon":153},[157,160],{"name":158,"role":57,"phone":159,"phoneExt":53,"email":59},"Katy Ward","01522572890",{"name":161,"role":81,"phone":53,"phoneExt":53,"email":53},"Alun Roebuck",{"facility":163,"status":63,"city":164,"state":165,"zip":166,"country":67,"countryCode":68,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"North Tees & Hartlepool NHS Foundation Trust","Hardwick","Stockton-on-Tees","TS19 8PE",{"type":70,"coordinates":168},[169,170],1.26746,52.46032,{"lat":170,"lon":169},[173,176],{"name":174,"role":57,"phone":175,"phoneExt":53,"email":59},"Karen Hann","01642 617617",{"name":174,"role":81,"phone":53,"phoneExt":53,"email":53},{"facility":178,"status":179,"city":180,"state":53,"zip":181,"country":67,"countryCode":68,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Ulster Hospital","NOT_YET_RECRUITING","Belfast","BT16 1RH",{"type":70,"coordinates":183},[184,185],-5.92541,54.59682,{"lat":185,"lon":184},[188,191],{"name":189,"role":57,"phone":190,"phoneExt":53,"email":59},"Dr Patrick Donnelly","028 9048 4511",{"name":192,"role":81,"phone":53,"phoneExt":53,"email":53},"Patrick Donnelly, Dr",{"facility":194,"status":63,"city":195,"state":53,"zip":196,"country":67,"countryCode":68,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Princess of Wales Hospital","Bridgend","CF31 1RQ",{"type":70,"coordinates":198},[199,200],-3.57722,51.50583,{"lat":200,"lon":199},[203,206,208],{"name":204,"role":57,"phone":205,"phoneExt":53,"email":59},"Gabby Williams","01443 443443",{"name":207,"role":81,"phone":53,"phoneExt":53,"email":53},"Aaron Wong, Dr",{"name":204,"role":209,"phone":53,"phoneExt":53,"email":53},"SUB_INVESTIGATOR",{"facility":211,"status":63,"city":212,"state":53,"zip":213,"country":67,"countryCode":68,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)","Glasgow","G51 4TF",{"type":70,"coordinates":215},[216,217],-4.25763,55.86515,{"lat":217,"lon":216},[220,223],{"name":221,"role":57,"phone":222,"phoneExt":53,"email":59},"Pierpaolo Pellicori, Dr","01412327599",{"name":221,"role":81,"phone":53,"phoneExt":53,"email":53},{"facility":225,"status":179,"city":117,"state":53,"zip":226,"country":67,"countryCode":68,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Hull University Teaching Hospitals NHS Trust","HU3 2JZ",{"type":70,"coordinates":228},[229,230],-0.33525,53.7446,{"lat":230,"lon":229},[233,236,238],{"name":234,"role":57,"phone":235,"phoneExt":53,"email":59},"Joe Cuthbert","01482 875875",{"name":237,"role":81,"phone":53,"phoneExt":53,"email":53},"Joe Cuthbert, Dr",{"name":239,"role":209,"phone":53,"phoneExt":53,"email":53},"Elton Luo, Dr",{"facility":241,"status":63,"city":242,"state":53,"zip":243,"country":67,"countryCode":68,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"St George's Hospital","London","SW17 0QT",{"type":70,"coordinates":245},[246,247],-0.12574,51.50853,{"lat":247,"lon":246},[250,253,255],{"name":251,"role":57,"phone":252,"phoneExt":53,"email":59},"Sinead Lyons","02087254404",{"name":254,"role":81,"phone":53,"phoneExt":53,"email":53},"Robin Ray, Dr",{"name":251,"role":209,"phone":53,"phoneExt":53,"email":53},{"facility":257,"status":63,"city":258,"state":53,"zip":259,"country":67,"countryCode":68,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Manchester University NHS Foundation Trust","Manchester","M13 9WL",{"type":70,"coordinates":261},[262,263],-2.23743,53.48095,{"lat":263,"lon":262},[266,269],{"name":267,"role":57,"phone":268,"phoneExt":53,"email":59},"Cathy Spence","01612761234",{"name":270,"role":81,"phone":53,"phoneExt":53,"email":53},"Fozia Ahmed, Dr",{"facility":272,"status":63,"city":273,"state":53,"zip":274,"country":67,"countryCode":68,"cosmosGeoPoint":275,"geoPoint":279,"contacts":280},"Milton Keynes University Hospital NHS Foundation Trust","Milton Keynes","MK6 5LD",{"type":70,"coordinates":276},[277,278],-0.75583,52.04172,{"lat":278,"lon":277},[281,284],{"name":282,"role":57,"phone":283,"phoneExt":53,"email":59},"Soma Hajdu","01908 660033",{"name":285,"role":81,"phone":53,"phoneExt":53,"email":53},"Attila Kardos, Prof",{"facility":287,"status":63,"city":288,"state":53,"zip":289,"country":67,"countryCode":68,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Chilwell Valley and Meadows Practice","Nottingham","NG9 6DX",{"type":70,"coordinates":291},[292,293],-1.15047,52.9536,{"lat":293,"lon":292},[296,299],{"name":297,"role":57,"phone":298,"phoneExt":53,"email":59},"Ed Longridge","01159462767",{"name":300,"role":81,"phone":53,"phoneExt":53,"email":53},"Kunaal Shah, Dr",{"facility":302,"status":179,"city":303,"state":53,"zip":304,"country":67,"countryCode":68,"cosmosGeoPoint":305,"geoPoint":309,"contacts":310},"Livewell Southwest","Plymouth","PL6 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9PS",{"type":70,"coordinates":335},[336,337],-1.98396,52.58528,{"lat":337,"lon":336},[340,343],{"name":341,"role":57,"phone":342,"phoneExt":53,"email":59},"Ben Jones","01922 605792",{"name":344,"role":81,"phone":53,"phoneExt":53,"email":53},"Rumi Jaumdally, Dr",{"type":346,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[348,350],{"name":257,"class":349},"OTHER_GOV",{"name":351,"class":31},"University of Glasgow","100598143","monitoring-oedema-in-heart-failure-to-improve-function-and-reduce-hospitalisation-risk-100598143",false,"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","ALL","18 Years",{"count":362,"type":363},300,"ESTIMATED","INTERVENTIONAL",[366],"NA","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.",[369],"Heart Failure",[371,372,373],"Peripheral Oedema","Heart Failure Decomposition","Heart Failure Hospitalization","2026-05-19",{"date":376,"type":377},"2026-05-20","ACTUAL",{"date":379,"type":377},"2025-12-18",{"date":381,"type":363},"2027-07-31",{"name":5,"class":6},18]