[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467989":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":49,"responsibleParty":309,"collaborators":311,"id":315,"slug":316,"hasResults":317,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":317,"sex":323,"minAge":324,"maxAge":26,"enrollmentInfo":325,"targetDuration":26,"studyType":328,"phases":329,"briefSummary":331,"conditions":332,"keywords":336,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":350},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heart failure optimal therapy alone (HFOT)","EXPERIMENTAL","Heart failure Optimal therapy without implantable cardioverter defibrillator. This group will not undergo an ICD implantation. They will be treated according to the HFOT recommended in the latest guidelines.",[13],"Device: No ICD implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Heart failure optimal therapy (HFOT) + Implantable cardioverter defibrillator (ICD)","ACTIVE_COMPARATOR","Optimal medical therapy + implantable cardioverter defibrillator (HFOT+ICD). This group will undergo an ICD implantation (standard of care), any brand, CE marked, implantable (lifelong), available and reimbursed in the French market (the type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization.",[19],"Device: ICD implantation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ICD implantation","This group will undergo an ICD implantation (type and manufacturer at the discretion of the local investigator) in addition to heart failure medical therapy optimization.\n\nPatients of the \"HFOT+ICD\" group will be scheduled for ICD implantation.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"No ICD implantation","Patients of the \"HFOT alone\" group will not undergo ICD implantation (except if they develop sustained ventricular arrhythmias and fulfil for secondary prevention ICD implantation), and continue with medical therapy optimization only.",[9],[32,36],{"name":33,"affiliation":34,"role":35},"Eloi MARIJON, MD, PhD","AP-HP, Hôpital européen Georges Pompidou, Paris","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Rodrigue GARCIA, MD, PhD","CHU Poitiers, France","STUDY_DIRECTOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Alexandra BRUNEAU, Mrs","CONTACT","+33144841712","alexandra.bruneau@aphp.fr",{"name":33,"role":43,"phone":47,"phoneExt":26,"email":48},"+33156093692","eloi.marijon@aphp.fr",[50,68,81,95,109,123,137,151,164,178,190,201,212,225,239,253,267,281,295],{"facility":51,"status":52,"city":53,"state":26,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Centre Hospitalier d'Aix en provence","RECRUITING","Aix-en-Provence","13616","France","FR",{"type":58,"coordinates":59},"Point",[60,61],5.44973,43.5283,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":66,"phoneExt":26,"email":67},"Jérôme TAIEB, MD","04 42 33 50 53","jtaieb@ch-aix.fr",{"facility":69,"status":52,"city":70,"state":26,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"CHU Amiens-Picardie-Site sud","Amiens","80054",{"type":58,"coordinates":73},[74,75],2.3,49.9,{"lat":75,"lon":74},[78],{"name":79,"role":43,"phone":26,"phoneExt":26,"email":80},"Alexis HERMIDA-JARRY, MD","hermida.alexis@chu-amiens.fr",{"facility":82,"status":52,"city":83,"state":26,"zip":84,"country":55,"countryCode":56,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"CHU Brest - Hôpital La Cavale Blanche","Brest","29200",{"type":58,"coordinates":86},[87,88],-4.48628,48.39029,{"lat":88,"lon":87},[91],{"name":92,"role":43,"phone":93,"phoneExt":26,"email":94},"Jacques MANSOURATI, Pr","02 98 34 73 73","jacques.mansourati@chu-brest.fr",{"facility":96,"status":52,"city":97,"state":26,"zip":98,"country":55,"countryCode":56,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"HôpitalHenri Mondor","Créteil","94000",{"type":58,"coordinates":100},[101,102],2.46569,48.79266,{"lat":102,"lon":101},[105],{"name":106,"role":43,"phone":107,"phoneExt":26,"email":108},"Nicolas LELLOUCHE, MD, PhD","0149814350","nicolas.lellouche@aphp.fr",{"facility":110,"status":52,"city":111,"state":26,"zip":112,"country":55,"countryCode":56,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"CHU Grenoble Alpes","La Tronche","38700",{"type":58,"coordinates":114},[115,116],5.74629,45.20507,{"lat":116,"lon":115},[119],{"name":120,"role":43,"phone":121,"phoneExt":26,"email":122},"Pascal DEFAYE, MD, PhD","04 76 76 75 75","pdefaye@chu-grenoble.fr",{"facility":124,"status":52,"city":125,"state":26,"zip":126,"country":55,"countryCode":56,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Groupement d'Hôpitaux de l'Institut Catholique de Lille","Lomme","59462",{"type":58,"coordinates":128},[129,130],2.98715,50.64358,{"lat":130,"lon":129},[133],{"name":134,"role":43,"phone":135,"phoneExt":26,"email":136},"Aymeric MENET, MD","03 20 22 50 57","menet.aymeric@ghicl.net",{"facility":138,"status":52,"city":139,"state":26,"zip":140,"country":55,"countryCode":56,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Hôpital de La Timone","Marseille","13385",{"type":58,"coordinates":142},[143,144],5.38107,43.29695,{"lat":144,"lon":143},[147],{"name":148,"role":43,"phone":149,"phoneExt":26,"email":150},"Jean Claude DEHARO, MD, PhD","04 91 38 65 90","jean-claude.deharo@ap-hm.fr",{"facility":152,"status":52,"city":153,"state":26,"zip":154,"country":55,"countryCode":56,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Hôpital de Brabois","Nancy","54710",{"type":58,"coordinates":156},[157,158],6.18496,48.68439,{"lat":158,"lon":157},[161],{"name":162,"role":43,"phone":26,"phoneExt":26,"email":163},"Mathieu ECHIVARD, MD","m.echivard@chru-nancy.fr",{"facility":165,"status":52,"city":166,"state":26,"zip":167,"country":55,"countryCode":56,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"CHU de Nantes","Nantes","44093",{"type":58,"coordinates":169},[170,171],-1.55336,47.21725,{"lat":171,"lon":170},[174],{"name":175,"role":43,"phone":176,"phoneExt":26,"email":177},"Vincent PROBST, MD, PhD","02 40 16 50 08","vincent.probst@chu-nantes.fr",{"facility":179,"status":52,"city":180,"state":26,"zip":181,"country":55,"countryCode":56,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Hôpital européen Georges Pompidou","Paris",", 75015",{"type":58,"coordinates":183},[184,185],2.3488,48.85341,{"lat":185,"lon":184},[188],{"name":33,"role":43,"phone":189,"phoneExt":26,"email":48},"01 56 09 36 92",{"facility":191,"status":52,"city":180,"state":26,"zip":192,"country":55,"countryCode":56,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"Hôpital Pitié-Salpétrière","75013",{"type":58,"coordinates":194},[184,185],{"lat":185,"lon":184},[197],{"name":198,"role":43,"phone":199,"phoneExt":26,"email":200},"Estelle GANDJBAKHCH, MD, PhD","01 42 16 30 55","estelle.gandjbakhch@aphp.fr",{"facility":202,"status":52,"city":180,"state":26,"zip":203,"country":55,"countryCode":56,"cosmosGeoPoint":204,"geoPoint":206,"contacts":207},"Hôpital Bichat - Claude Bernard","75014",{"type":58,"coordinates":205},[184,185],{"lat":185,"lon":184},[208],{"name":209,"role":43,"phone":210,"phoneExt":26,"email":211},"Fabrice EXTRAMIANA, MD, PhD","0140258236","fabrice.extramiana@aphp.fr",{"facility":213,"status":52,"city":214,"state":26,"zip":215,"country":55,"countryCode":56,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"CHU Poitiers","Poitiers","86021",{"type":58,"coordinates":217},[218,219],0.34348,46.58261,{"lat":219,"lon":218},[222],{"name":223,"role":43,"phone":26,"phoneExt":26,"email":224},"Rodrigue Garcia, MD, PhD","rodrigue.garcia@chu-poitiers.fr",{"facility":226,"status":52,"city":227,"state":26,"zip":228,"country":55,"countryCode":56,"cosmosGeoPoint":229,"geoPoint":233,"contacts":234},"Hôpital Pontchaillou","Rennes","35033",{"type":58,"coordinates":230},[231,232],-1.67431,48.11109,{"lat":232,"lon":231},[235],{"name":236,"role":43,"phone":237,"phoneExt":26,"email":238},"Christophe LECLERCQ, MD","0299282525","christophe.leclercq@chu-rennes.fr",{"facility":240,"status":52,"city":241,"state":26,"zip":242,"country":55,"countryCode":56,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"CHU de Rouen","Rouen","76000",{"type":58,"coordinates":244},[245,246],1.09932,49.44313,{"lat":246,"lon":245},[249],{"name":250,"role":43,"phone":251,"phoneExt":26,"email":252},"Frédéric ANSELME, MD, PhD","02 32 88 81 11","frederic.anselme@chu-rouen.fr",{"facility":254,"status":52,"city":255,"state":26,"zip":256,"country":55,"countryCode":56,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Centre Cardiologique du Nord","Saint-Denis","93207",{"type":58,"coordinates":258},[259,260],2.35387,48.93564,{"lat":260,"lon":259},[263],{"name":264,"role":43,"phone":265,"phoneExt":26,"email":266},"Olivier PIOT, MD","01 49 33 41 82","o.piot@ccn.fr",{"facility":268,"status":52,"city":269,"state":26,"zip":270,"country":55,"countryCode":56,"cosmosGeoPoint":271,"geoPoint":275,"contacts":276},"CHU Strasbourg","Strasbourg","67200",{"type":58,"coordinates":272},[273,274],7.74553,48.58392,{"lat":274,"lon":273},[277],{"name":278,"role":43,"phone":279,"phoneExt":26,"email":280},"Laurence JESEL-MOREL, MD, PhD","03 69 55 09 48","laurence.jesel-morel@chru-strasbourg.fr",{"facility":282,"status":52,"city":283,"state":26,"zip":284,"country":55,"countryCode":56,"cosmosGeoPoint":285,"geoPoint":289,"contacts":290},"Clinique Pasteur","Toulouse","31076",{"type":58,"coordinates":286},[287,288],1.44367,43.60426,{"lat":288,"lon":287},[291],{"name":292,"role":43,"phone":293,"phoneExt":26,"email":294},"Serge BOVEDA, MD, PhD","05 62 21 16 45","sboveda@clinique-pasteur.com",{"facility":296,"status":52,"city":297,"state":26,"zip":298,"country":55,"countryCode":56,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Hôpital Trousseau","Tours","37170",{"type":58,"coordinates":300},[301,302],0.70398,47.39484,{"lat":302,"lon":301},[305],{"name":306,"role":43,"phone":307,"phoneExt":26,"email":308},"Laurent FAUCHIER, MD","02 47 47 87 83","laurent.fauchier@univ-tours.fr",{"type":310,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[312],{"name":313,"class":314},"Ministry of Health, France","OTHER_GOV","100467989","cardioverter-defibriilator-placement-for-primary-prevention-of-sudden-cardiac-death-in-patients-older-than-70-years-100467989",false,"NCT05373940","Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years","Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years: A Randomized Controlled Trial","DILEMMA","Inclusion Criteria:\n\n* ≥70 years old,\n* Left ventricular ejection fraction ≤ 35%, assessed by echocardiography, single-photon emission computed tomography and radionuclide ventriculography and\u002For cardiac magnetic resonance (CMR) (assessed at inclusion or within the 6 weeks prior to inclusion).\n* NYHA class II or III\n* Heart failure HFOT ≥ 3 months (Possible exceptions : possibility of including patients who do not tolerate the maximum dose or who do not tolerate all four therapeutic classes, as well as the possibility of not waiting for three months when one of the classes is discontinued or when dosage adjustments are made due to poor tolerance ...)\n* Providing informed consent\n* Affiliated to a French Health Insurance system.\n\nExclusion Criteria:\n\n* Enrolled in or planning to enroll in a conflicting interventional trial (trial evaluating the interest of ICD or modifying HFOT outside the last ESC Guidelines)\n* Prior unstable sustained ventricular arrhythmia requiring external cardioversion\n* Myocardial infarction within the 40 days\n* Coronary artery intervention (catheter or surgical) within 90 days\n* History of syncope in the previous 6 months\n* Advanced cerebrovascular disease (cerebrovascular disease with functional repercussions or effect on the patient's autonomy)\n* Cognitive impairment leading to the incapacity of consent\n* Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.\n* Patient under tutorship, curatorship, or legal safeguard\n* Persons deprived of their liberty by judicial or administrative decision (prisoner)","ALL","70 Years",{"count":326,"type":327},730,"ESTIMATED","INTERVENTIONAL",[330],"NA","The primary objective of DILEMMA study is to assess whether the \"heart failure optimal therapy alone (HFOT)\" strategy is non inferior to the \"HFOT+ICD\" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.",[333,334,335],"Heart Failure","Primary Prevention of Sudden Cardiac Death","Implantable Cardioverter Defibrillator",[333,337,338,339,340],"Prevention strategy of Sudden Cardiac Death","Implantable cardioverter defibrillator","Heart Failure Optimal Therapy","Mortality","2026-03-23",{"date":343,"type":344},"2026-03-24","ACTUAL",{"date":346,"type":344},"2022-06-29",{"date":348,"type":327},"2030-05-31",{"name":5,"class":6},19]