nctId: NCT06356727 id: 121CET-MICROREV-DCM briefTitle: Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling acronym: MICROREV overallStatus: RECRUITING date: 2024-01-03 date: 2026-01-31 date: 2030-01-31 date: 2024-04-10 date: 2024-04-10 name: Azienda Ospedaliera Universitaria Integrata Verona class: OTHER name: Abbott Medical Devices briefSummary: Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), 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. conditions: Heart Failure conditions: Left Ventricular Dysfunction conditions: Idiopathic Dilated Cardiomyopathy studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: Prospective multicenter single-arm experimental study. The study aims to perform a functional study of the coronary microcirculation with pressure guides, in patients with new diagnoses of dilated cardiomyopathy and clinical indication for coronary angiography. Following this, a multiparametric imaging study with transthoracic echo cardiography will be performed. 12 months after the optimization of medical therapy, the patient will receive a clinical, laboratory and instrumental re-evaluation of transthoracic cardiac color Doppler. The primary endpoint is the recovery of left ventricular function on cardiac imaging. Follow up will continue up to 5 years from enrollment through telephone contacts, outpatient visits and review of clinical data. primaryPurpose: SUPPORTIVE_CARE masking: NONE count: 190 type: ESTIMATED name: Thermodilution based assessment of coronary microcirculation measure: Rate of Left ventricular reverse remodeling (LVRR) measure: Adverse clinical events measure: Rate of LVRR at cardiac magnetic resonance measure: Changes in functional capacity at cardiopulmonary exercise test measure: Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling. measure: Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance. sex: ALL minimumAge: 18 Years maximumAge: 85 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Azienda Ospedaliera Universitaria di Ferrara status: NOT_YET_RECRUITING city: Ferrara country: Italy name: Gianluca Campo role: CONTACT name: Elisabetta Tonet role: CONTACT lat: 44.83804 lon: 11.62057 facility: Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino status: NOT_YET_RECRUITING city: Genova country: Italy name: Italo Porto role: CONTACT lat: 44.40478 lon: 8.94438 facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele status: NOT_YET_RECRUITING city: Milan country: Italy name: Matteo Montorfano role: CONTACT name: Marco Ancona role: CONTACT lat: 45.46427 lon: 9.18951 facility: Ospedale Galeazzi di Sant'Ambrogio IRCCS status: NOT_YET_RECRUITING city: Milan country: Italy name: Giovanni Monizzi role: CONTACT lat: 45.46427 lon: 9.18951 facility: University of Naples Federico II status: NOT_YET_RECRUITING city: Naples country: Italy name: Giovanni Esposito role: CONTACT name: Luigi Di Serafino role: CONTACT lat: 40.85216 lon: 14.26811 facility: Fondazione Policlinico Universitario A. Gemelli IRCCS status: NOT_YET_RECRUITING city: Roma country: Italy name: Cristina Aurigemma role: CONTACT name: Francesco Burzotta role: CONTACT name: Antonio M Leone role: SUB_INVESTIGATOR lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Sant'Andrea status: NOT_YET_RECRUITING city: Rome country: Italy name: Emanuele Barbato role: CONTACT lat: 41.89193 lon: 12.51133 facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino status: NOT_YET_RECRUITING city: Torino country: Italy name: Fabrizio D'Ascenzo role: CONTACT lat: 45.07049 lon: 7.68682 facility: Azienda Ospedaliera Universitaria di Verona status: RECRUITING city: Verona zip: 37126 country: Italy name: Flavio Ribichini role: CONTACT phone: 0039 0458122320 email: flavio.ribichini@univr.it lat: 45.4299 lon: 10.98444 hasResults: False