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Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Summary
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.
Official title: Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
190
Start Date
2024-01-03
Completion Date
2030-01-31
Last Updated
2024-04-10
Healthy Volunteers
No
Interventions
Thermodilution based assessment of coronary microcirculation
Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.
Locations (9)
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino
Genova, Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele
Milan, Italy
Ospedale Galeazzi di Sant'Ambrogio IRCCS
Milan, Italy
University of Naples Federico II
Naples, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Azienda Ospedaliera Universitaria di Verona
Verona, Italy