[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100405388":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":37,"responsibleParty":57,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":18,"enrollmentInfo":74,"targetDuration":18,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":18,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Luebeck","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ICD group","EXPERIMENTAL","Patients receiving OMT and ICD or cardiac resynchronization therapy with a defibrillator (CRT-D) if indicated.",[13],"Other: ICD\u002FCRT-D implantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Optimal HF care group","NO_INTERVENTION","Patients receiving OMT and CRT pacemaker (CRT-P) implantation without a defibrillator if indicated. Patients without CRT indication will receive an ICM for detection of malignant VAs.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"ICD\u002FCRT-D implantation","ICD\u002FCRT-D implantation (if indicated)",[9],[25],{"name":26,"affiliation":27,"role":28},"Ingo Eitel, Prof. Dr.","Medical Clinic II - University Heart Center Lübeck","PRINCIPAL_INVESTIGATOR",[30,34],{"name":26,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+49 451 500 44501","ingo.eitel@uksh.de",{"name":35,"role":31,"phone":32,"phoneExt":18,"email":36},"Thomas Stiermaier, Dr.","thomas.stiermaier@uksh.de",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Universität zu Lübeck","RECRUITING","Lübeck","Schleswig-Holstein","23538","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],10.68729,53.86893,{"lat":50,"lon":49},[53,55],{"name":54,"role":31,"phone":18,"phoneExt":18,"email":18},"Ingo Eitel, Prof. Dr. med.",{"name":56,"role":31,"phone":18,"phoneExt":18,"email":18},"Thomas Stiermaier, Dr.med",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Prof. Dr. med. Ingo Eitel","Director",[62],{"name":63,"class":6},"Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)","100405388","cardiac-magnetic-resonance-guidance-of-implantable-cardioverter-defibrillator-implantation-in-non-ischemic-dilated-cardiomyopathy-100405388",false,"NCT04558723","Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy","Randomized Controlled, Multi-centre Trial of Cardiac Magnetic Resonance Guidance of Implantable Cardioverter Defibrillator Implantation in Non-ischemic Dilated Cardiomyopathy","CMR-ICD","Inclusion Criteria:\n\n* NIDCM (idiopathic or familial)\\*\n* LVEF ≤35% and presence of fibrosis on CMR\n* Diagnostic CMR scan\n* Age ≥18 years\n* Written informed consent\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* ICM \\[previous myocardial infarction, previous percutaneous coronary intervention\\]\n* Other cardiomyopathies (hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathies \\[e.g. cardiac amyloidosis, cardiac sarcoidosis, hemochromatosis and iron overload cardiomyopathy\\], left ventricular non-compaction cardiomyopathy, reversible cardiomyopathies \\[Takotsubo syndrrome, peripartum cardiomyopathy, chemotherapy induced cardiomyopathy\\].\n* Myocarditis\n* Contraindication for CMR at study entry (including severe claustrophobia, pacemaker or ICD, metallic cerebral or intracranial implants, known allergy to gadolinium)\n* Severe renal insufficiency (creatinine clearance \\\u003C30 mL\u002Fmin)\n* Current pacemaker or defibrillator in situ\n* Current indication for device therapy (e.g. secondary prophylaxis after aborted SCD)\n* Renal impairment defined as an eGFR \\\u003C30 milliliters\n* Age \\\u003C18 years\n* Patients presenting with pregnancy\n* Patients without informed consent\n* Participation in another randomized trial\n* Life expectancy \\\u003C2 years","ALL","18 Years",{"count":75,"type":76},760,"ESTIMATED","INTERVENTIONAL",[79],"NA","Patients with diagnostic CMR images for assessment of LGE\u002Ffibrosis and evidence\u002Fpresence of non-ischaemic myocardial fibrosis\u002Fscar will be randomized to the following treatment groups in a 1:1 ratio: ICD group or Optimal HF care group.",[82],"Non-ischemic Dilated Cardiomyopathy","2024-05-10",{"date":85,"type":86},"2024-05-13","ACTUAL",{"date":88,"type":86},"2021-01-14",{"date":90,"type":76},"2027-11",{"name":59,"class":6},1]