Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Recruiting · NCT06356727 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
9 locations listed.
- 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