Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
Azienda Ospedaliera Universitaria Integrata Verona
190 participants
Jan 3, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria15
- 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
Interventions
Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.
Locations(9)
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NCT06356727