Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
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
| Condition(s) | Heart Failure, Left Ventricular Dysfunction, Idiopathic Dilated Cardiomyopathy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Lead sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
| Locations | Ferrara, Italy; Genova, Italy; Milan, Italy; Milan, Italy; Naples, Italy; Roma, Italy (+3 more sites) |
| Start date | 2024-01-03 |
| NCT ID | NCT06356727 |
| Official listing | https://clinicaltrials.gov/study/NCT06356727 |