protocolSection identificationModule nctId: NCT06356727, orgStudyIdInfo id: 121CET-MICROREV-DCM, briefTitle: Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling, acronym: MICROREV, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-03, primaryCompletionDateStruct date: 2026-01-31, completionDateStruct date: 2030-01-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Universitaria Integrata Verona, class: OTHER, collaborators name: Abbott Medical Devices, descriptionModule 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., conditionsModule conditions: Heart Failure, conditions: Left Ventricular Dysfunction, conditions: Idiopathic Dilated Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: NONE, enrollmentInfo count: 190, type: ESTIMATED, armsInterventionsModule interventions name: Thermodilution based assessment of coronary microcirculation, outcomesModule primaryOutcomes measure: Rate of Left ventricular reverse remodeling (LVRR), secondaryOutcomes measure: Adverse clinical events, secondaryOutcomes measure: Rate of LVRR at cardiac magnetic resonance, secondaryOutcomes measure: Changes in functional capacity at cardiopulmonary exercise test, secondaryOutcomes measure: Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling., secondaryOutcomes measure: Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliera Universitaria di Ferrara, status: NOT_YET_RECRUITING, city: Ferrara, country: Italy, contacts name: Gianluca Campo, role: CONTACT, contacts name: Elisabetta Tonet, role: CONTACT, geoPoint lat: 44.83804, lon: 11.62057, locations facility: Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino, status: NOT_YET_RECRUITING, city: Genova, country: Italy, contacts name: Italo Porto, role: CONTACT, geoPoint lat: 44.40478, lon: 8.94438, locations facility: Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele, status: NOT_YET_RECRUITING, city: Milan, country: Italy, contacts name: Matteo Montorfano, role: CONTACT, contacts name: Marco Ancona, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Ospedale Galeazzi di Sant'Ambrogio IRCCS, status: NOT_YET_RECRUITING, city: Milan, country: Italy, contacts name: Giovanni Monizzi, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: University of Naples Federico II, status: NOT_YET_RECRUITING, city: Naples, country: Italy, contacts name: Giovanni Esposito, role: CONTACT, contacts name: Luigi Di Serafino, role: CONTACT, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, status: NOT_YET_RECRUITING, city: Roma, country: Italy, contacts name: Cristina Aurigemma, role: CONTACT, contacts name: Francesco Burzotta, role: CONTACT, contacts name: Antonio M Leone, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Sant'Andrea, status: NOT_YET_RECRUITING, city: Rome, country: Italy, contacts name: Emanuele Barbato, role: CONTACT, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, status: NOT_YET_RECRUITING, city: Torino, country: Italy, contacts name: Fabrizio D'Ascenzo, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, locations facility: Azienda Ospedaliera Universitaria di Verona, status: RECRUITING, city: Verona, zip: 37126, country: Italy, contacts name: Flavio Ribichini, role: CONTACT, phone: 0039 0458122320, email: flavio.ribichini@univr.it, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False