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Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

RecruitingNAAges 18 Years - 85 YearsAllAzienda Ospedaliera Universitaria Integrata Verona
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female, aged \>18 years * First diagnosis of idiopathic DCM (defined according to the most recent ESC Guidelines) with LVEF ≤ 40% and clinical indication to diagnostic coronary angiography * Willing and able to give informed consent for participation in the study Exclusion Criteria: * Obstructive CAD (defined as angiographically intermediate disease \[50%-70%\] with impaired FFR or as angiographically severe disease \[\>70%\] in 1 or more epicardial vessels) * History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery * Valvular heart disease (rheumatic heart disease, severe aortic stenosis, severe aortic regurgitation, severe primary mitral regurgitation) * Infective endocarditis * Congenital heart disease * Peripartum cardiomyopathy * Acute myocarditis (detected by endomyocardial biopsy - histological criteria - or by CMR - Lake Louis criteria) and pericarditis * Persistent tachyarrhythmias (documented persistent high-rate supraventricular arrhythmias) * Excessive alcohol intake (\>80 g/die for at least five years) * History of chemotherapy (anthracycline therapy, cumulative dosages \>250 mg/m2) * History of uncontrolled arterial hypertension (blood pressure \>160/100 mmHg) * Stage IV and V of chronic kidney disease (eGFR \< 30 ml/min, estimated through CKD - EPI Creatinine Equation) * Allergy or other contraindication to iodinated contrast and/or adenosine * Chronic resting O2 saturation \<85% * Pregnancy or suspected pregnancy
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What it tests

  • Thermodilution based assessment of coronary microcirculation
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Where

9 sites
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

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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