[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362020":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":18,"responsibleParty":39,"collaborators":18,"id":42,"slug":18,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":18,"enrollmentInfo":50,"targetDuration":18,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":18,"overallStatus":61,"whyStopped":18,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":18},{"fullName":5,"class":6},"Flinders University","OTHER",[8,14],{"label":9,"type":6,"description":10,"interventionNames":11},"Device Implantation","A prospective, blocked, randomised, controlled trial of primary prophylaxis ICD therapy or ILR insertion in patients with LVEF \\\u003C45% and LGE on CMR.",[12,13],"Device: ICD","Device: ILR",{"label":15,"type":16,"description":17,"interventionNames":18},"Observational Registry","NO_INTERVENTION","A prospective observational registry of patients with LVEF \\\u003C45% and no LGE on CMR.",null,[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","ICD","Insertion of ICD in patients with LVEF \\\u003C45% and LGE on CMR.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":18},"ILR","Insertion of ILR in patients with LVEF \\\u003C45% and LGE on CMR.",[9],[30],{"name":31,"affiliation":32,"role":33},"Joseph B Selvanayagam, MBBS","Flinders Medical Centre","PRINCIPAL_INVESTIGATOR",[35],{"name":31,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","+61 8 8404 2195","joseph.selvanayagam@flinders.edu.au",{"type":33,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Joseph Selvanayagam","Principal Investigator","100362020",false,"NCT03993730","Cardiovascular Magnetic Resonance GUIDEd Insertion of Implantable Cardiac Defibrillator in Dilated CardioMyopathy","CMR GUIDE DCM","Inclusion Criteria:\n\n* Age greater than\u002Fequal to 18 years old\n* Non-ischemic cardiomyopathy of dilated type\n* Left Ventricular Ejection Fraction \\\u003C 45%\n* Able and willing to comply with all pre, post and follow-up testing and requirements\n* On maximum tolerated doses of angiotensin converting enzyme (ACE) inhibitors (or Angiotensin Receptor Blockers(ARB) or Neprilysin Inhibitors) and Beta Blockers\n\nExclusion Criteria:\n\n1. Known coronary artery disease (CAD) (History of Myocardial Infarction or Significant Epicardial CAD on Angiography)\n2. Hypertrophic Cardiomyopathy\n3. Cardiomyopathy related to sarcoidosis\n4. Arrhythmogenic Right Ventricular Dysplasia\n5. Standard LGE CMR contraindications (e.g. severe claustrophobia, metal)\n6. Currently implanted permanent pacemaker and\u002For pacemaker\u002FICD lead\n7. Clinical indication for ICD or pacemaker or Cardiac Resynchronisation Therapy\n8. Contraindications to intravenous Gadolinium\n9. Severe renal insufficiency (eGFR\\\u003C 45mls\u002Fmin\u002F1.73m2 )\n10. New York Heart Association Heart Failure functional class IV\n11. Conditions associated with life expectancy \\\u003C1 year\n12. Pregnancy or in females of child-bearing potential, the non-use of accepted forms of contraception","ALL","18 Years",{"count":51,"type":52},1880,"ESTIMATED","INTERVENTIONAL",[55],"NA","CMR GUIDE DCM is a randomized controlled trial with a registry for non-randomized patients.\n\nPatients enrolled will have non-ischemic cardiomyopathy (NICM) with mild to severe Left Ventricular (LV) systolic dysfunction with replacement fibrosis identified on Cardiac Magnetic Resonance (CMR).\n\n954 patients will be randomised from 50 sites across 4-6 countries worldwide to receive an implantable defibrillator (ICD) or implantable loop recorder (ILR).\n\nDevice and clinical follow-up will be performed at 3, 6, 12, 24, 36 months and at end of study.",[58,59,60],"Dilated Cardiomyopathy","Left Ventricular Systolic Dysfunction","Fibrosis Myocardial","NOT_YET_RECRUITING","2019-06-20",{"date":64,"type":65},"2019-06-21","ACTUAL",{"date":67,"type":52},"2020-06",{"date":69,"type":52},"2026-06",{"name":5,"class":6}]