[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658472":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":16,"studyPopulation":16,"armGroups":50,"interventions":61,"overallOfficials":16,"centralContacts":67,"locations":73,"responsibleParty":123,"collaborators":126,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":16,"enrollmentInfo":145,"targetDuration":16,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":155,"overallStatus":76,"whyStopped":16,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Institut d'Investigació Biomèdica de Bellvitge","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Recurrence of left ventricular dysfunction or heart failure symptoms at 6 months","Any of the following events:\n\n* Decrease in LVEF \\>10% and final LVEF \\\u003C50%\n* Decrease in LVEF \\>10% and increase in LV end-systolic volume \\>15%\n* Appearance of heart failure symptoms accompanied by elevated NT-proBNP requiring initiation of oral, subcutaneous, or intravenous loop diuretic treatment.","6 months",[14,18,20,23,26,29,32,35,39],{"measure":15,"description":16,"timeFrame":17},"Emergency room or day hospital visits for heart failure",null,"6 and 12 months",{"measure":19,"description":16,"timeFrame":17},"Hospitalizations due to heart failure",{"measure":21,"description":22,"timeFrame":17},"Ventricular arrhythmias","Sustained ventricular tachycardia, sudden cardiac death, appropriate ICD therapy",{"measure":24,"description":25,"timeFrame":17},"Supraventricular arrhythmias","Sustained supraventricular arrhythmia, including sustained atrial fibrillation, sustained atrial flutter and sustained atrial tachycardia",{"measure":27,"description":28,"timeFrame":17},"NYHA class","New York Heart Association functional class, limits I-IV, higher scores means worse outcome",{"measure":30,"description":31,"timeFrame":17},"NtproBNP","levels of NTproBNP, as measured in blood sample",{"measure":33,"description":34,"timeFrame":17},"Quality of life, assessed with KCCQ","KCCQ: Kansas City Cardiomyopathy Questionnaire, minimum and maximum values 0-100, higher scores indicate better outcome",{"measure":36,"description":37,"timeFrame":38},"Quality of life as evaluated with the EQ-5D-5L, EQ VAS","EuroQol five-dimension, five-level questionnaire - visual analogue scale, minimum and maximum value 0-100, higher score indicates better outcome","6 months and 12 months",{"measure":40,"description":41,"timeFrame":38},"Quality of life evaluated with the EQ-5D-5L-index value","EuroQol five-dimension, five-level questionnaire - index value, minimum and maximum value 0-1, higher score indicates better outcome",{"allocation":43,"interventionModel":44,"interventionModelDescription":16,"primaryPurpose":45,"observationalModel":16,"timePerspective":16,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":16,"whoMasked":48},"SINGLE",[49],"OUTCOMES_ASSESSOR",[51,55],{"label":52,"type":53,"description":54,"interventionNames":16},"Control Group","NO_INTERVENTION","Continue heart failure medical tretment without changes",{"label":56,"type":57,"description":58,"interventionNames":59},"Drugs withdrawal group","ACTIVE_COMPARATOR","Heart failure medications are progressively withdrawn, in a máximum period of 9 weeks, always with the same protocol in every patient.",[60],"Drug: Withdrawal of Heart failure medications",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":16},"DRUG","Withdrawal of Heart failure medications","Heart failure drugs will be withdrawn progressively over a maximum of 9 weeks, discontinuing drugs one by one following a predefined sequence",[56],[68],{"name":69,"role":70,"phone":71,"phoneExt":16,"email":72},"Andrea Di Marco, MD, PhD","CONTACT","+34932607686","adimarco@bellvitgehospital.cat",[74,91,101,112],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Hospital Universitari de Bellvitge","RECRUITING","L'Hospitalet de Llobregat","Barcelona","08907","Spain","ES",{"type":83,"coordinates":84},"Point",[85,86],2.10028,41.35967,{"lat":86,"lon":85},[89],{"name":90,"role":70,"phone":71,"phoneExt":16,"email":72},"Andrea Di Marco",{"facility":92,"status":76,"city":78,"state":16,"zip":16,"country":80,"countryCode":81,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Hospital Vall d'Hebron",{"type":83,"coordinates":94},[95,96],2.15899,41.38879,{"lat":96,"lon":95},[99],{"name":100,"role":70,"phone":71,"phoneExt":16,"email":72},"Jaume Francisco Pascual",{"facility":102,"status":76,"city":103,"state":16,"zip":16,"country":80,"countryCode":81,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hospital Trueta","Girona",{"type":83,"coordinates":105},[106,107],2.82493,41.98311,{"lat":107,"lon":106},[110],{"name":111,"role":70,"phone":71,"phoneExt":16,"email":72},"Carles Moliner",{"facility":113,"status":76,"city":114,"state":16,"zip":16,"country":80,"countryCode":81,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Hospital Virgen de las Nieves","Granada",{"type":83,"coordinates":116},[117,118],-3.60667,37.18817,{"lat":118,"lon":117},[121],{"name":122,"role":70,"phone":71,"phoneExt":16,"email":72},"Laura Jordan",{"type":124,"investigatorFullName":90,"investigatorTitle":125,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"PRINCIPAL_INVESTIGATOR","MD, PhD",[127,129,131,132,134],{"name":128,"class":6},"University Hospital Virgen de las Nieves",{"name":130,"class":6},"Hospital de Sant Pau",{"name":92,"class":6},{"name":133,"class":6},"Hospital Universitario La Paz",{"name":75,"class":6},"100658472","phase-4-withdrawal-of-heart-failure-treatment-patients-with-non-ischemic-cardiomyopathy-who-have-been-super-responders-to-cardiac-resynchronization-therapy-100658472",false,"NCT07851779","Withdrawal of Heart Failure Treatment Patients With Non-ischemic Cardiomyopathy Who Have Been Super-responders to Cardiac Resynchronization Therapy.","Withdrawal of Heart Failure Treatment in Patients With Non-ischemic Cardiomyopathy, Without Late Gadolinium Enhancement and With a Negative Genetic Test, Who Have Been Super-responders to Cardiac Resynchronization Therapy.","DRUGLESS-CRT","Inclusion Criteria:\n\n* Diagnosis of non-ischemic cardiomyopathy\n* LBBB already present at the time of first diagnosis of LV dysfunction\n* Negative genetic test\n* Cardiac MRI with no evidence of late gadolinium enhancement (LGE at RV insertion points is acceptable)\n* Carrier of a resynchronization device (ICD or pacemaker, with LV epicardial pacing form a cardiac vein or left bundle area pacing), pacing percentage \\>95% and paced QRS \\\u003C140 ms\n* Device indication: LVEF ≤35% and LBBB with QRS \\>150 ms\n* LVEF ≥50% and normal indexed LV volumes on echocardiogram performed at least 6 months after CRT implantation\n* No heart failure decompensations (no hospitalizations or urgent\u002Fday hospital visits) since CRT implantation\n* No need for loop diuretic treatment\n* NYHA class I or II\n* NT-proBNP \\\u003C450 ng\u002FL (or \\\u003C1000 ng\u002FL in atrial fibrillation\u002Fflutter)\n* On neurohormonal therapy with at least two drugs\n\nExclusion Criteria:\n\n* Family history of non-ischemic cardiomyopathy with LVEF \\\u003C50% in at least one first-degree relative\n* Severe valvular heart disease\n* History of sustained ventricular arrhythmia or treated by ICD\n* Need to maintain beta-blocker therapy for other arrhythmias\n* Hypertension not controlled with other medications\n* CRT devices implanted as an upgrade from prior pacemaker or ICD, where prior pacing percentage was \\>20%\n* Clinical indication other than heart failure to maintain any of the neurohormonal treatment drugs (class I recommendation in ESC or ACC\u002FAHA guidelines)","ALL","18 Years",{"count":146,"type":147},64,"ESTIMATED","INTERVENTIONAL",[150],"PHASE4","Multicenter, prospective, non-inferiority, randomized, single-blind (primary endpoint evaluators blinded, patients not blinded) clinical trial.\n\nWe aim to evaluate if the withdrawal of heart failure treatment is safe in patients with non-ischemic cardiomyopathy, negative genetic test, no evidence of late gadolinium enhancement on cardiac MRI, who have been super-responders to cardiac resynchronization therapy and remain free of heart failure events for at least 6 months after device implantation.",[153,154],"Non-ischemic Cardiomyopathy","Cardiac Resynchronisation Therapy (CRT)",[156,157,158,159,160],"Heart failure medical treatment","Non-ischemic cardiomyopathy","Cardiac resynchronization therapy","Late gadolinium enhancement","Cardiogenetic","2026-09-25",{"date":163,"type":164},"2026-10-01","ACTUAL",{"date":166,"type":164},"2026-01-14",{"date":168,"type":147},"2027-07-31",{"name":5,"class":6},4]