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RECRUITING
NCT06356727
NA

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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