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Gemelli IRCCS","Roma",{"type":40,"coordinates":99},[100,101],11.10642,44.99364,{"lat":101,"lon":100},[104,106,108],{"name":105,"role":29,"phone":20,"phoneExt":20,"email":20},"Cristina Aurigemma",{"name":107,"role":29,"phone":20,"phoneExt":20,"email":20},"Francesco Burzotta",{"name":109,"role":110,"phone":20,"phoneExt":20,"email":20},"Antonio M Leone","SUB_INVESTIGATOR",{"facility":112,"status":35,"city":113,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Azienda Ospedaliero-Universitaria Sant'Andrea","Rome",{"type":40,"coordinates":115},[116,117],12.51133,41.89193,{"lat":117,"lon":116},[120],{"name":121,"role":29,"phone":20,"phoneExt":20,"email":20},"Emanuele Barbato",{"facility":123,"status":35,"city":124,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino","Torino",{"type":40,"coordinates":126},[127,128],11.99138,44.88856,{"lat":128,"lon":127},[131],{"name":132,"role":29,"phone":20,"phoneExt":20,"email":20},"Fabrizio D'Ascenzo",{"facility":24,"status":134,"city":135,"state":20,"zip":136,"country":37,"countryCode":38,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"RECRUITING","Verona","37126",{"type":40,"coordinates":138},[139,140],10.9938,45.43854,{"lat":140,"lon":139},[143],{"name":144,"role":29,"phone":30,"phoneExt":20,"email":145},"Flavio Ribichini","flavio.ribichini@univr.it",{"type":25,"investigatorFullName":147,"investigatorTitle":148,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Roberto Scarsini","Principal investigator",[150],{"name":151,"class":152},"Abbott Medical Devices","INDUSTRY","100543504","microvascular-dysfunction-assessment-to-predict-left-ventricular-reverse-remodeling-100543504",false,"NCT06356727","Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling","Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy","MICROREV","Inclusion Criteria:\n\n* Male or female, aged \\>18 years\n* First diagnosis of idiopathic DCM (defined according to the most recent ESC Guidelines) with LVEF ≤ 40% and clinical indication to diagnostic coronary angiography\n* Willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Obstructive CAD (defined as angiographically intermediate disease \\[50%-70%\\] with impaired FFR or as angiographically severe disease \\[\\>70%\\] in 1 or more epicardial vessels)\n* History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery\n* Valvular heart disease (rheumatic heart disease, severe aortic stenosis, severe aortic regurgitation, severe primary mitral regurgitation)\n* Infective endocarditis\n* Congenital heart disease\n* Peripartum cardiomyopathy\n* Acute myocarditis (detected by endomyocardial biopsy - histological criteria - or by CMR - Lake Louis criteria) and pericarditis\n* Persistent tachyarrhythmias (documented persistent high-rate supraventricular arrhythmias)\n* Excessive alcohol intake (\\>80 g\u002Fdie for at least five years)\n* History of chemotherapy (anthracycline therapy, cumulative dosages \\>250 mg\u002Fm2)\n* History of uncontrolled arterial hypertension (blood pressure \\>160\u002F100 mmHg)\n* Stage IV and V of chronic kidney disease (eGFR \\\u003C 30 ml\u002Fmin, estimated through CKD - EPI Creatinine Equation)\n* Allergy or other contraindication to iodinated contrast and\u002For adenosine\n* Chronic resting O2 saturation \\\u003C85%\n* Pregnancy or suspected pregnancy","ALL","18 Years","85 Years",{"count":165,"type":166},190,"ESTIMATED","INTERVENTIONAL",[169],"NA","Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \\\u003C40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance.",[172,173,174],"Heart Failure","Left Ventricular Dysfunction","Idiopathic Dilated Cardiomyopathy",[176,177,178,179],"coronary microvascular dysfunction","heart failure","left ventricular reverse remodeling","optimal medical therapy","2024-04-09",{"date":182,"type":183},"2024-04-10","ACTUAL",{"date":185,"type":183},"2024-01-03",{"date":187,"type":166},"2030-01-31",{"name":5,"class":6},9]