Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA · Apr 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how to better assess the health of small blood vessels in the heart to predict improvements in heart function for patients with a specific type of heart failure called idiopathic dilated cardiomyopathy. The study will involve patients who have a weakened heart muscle (with a measurement called left ventricular ejection fraction, or LVEF, of 40% or less) and who have not yet started medication to help their heart. Participants will undergo a specialized test to check their heart's microvascular health and will then receive optimal medical treatment for a year. After this period, the researchers will use ultrasound to see how much the heart function has improved.

Eligible participants are adults over 18 who have recently been diagnosed with idiopathic dilated cardiomyopathy and meet certain health criteria. Throughout the study, which lasts up to five years, participants may undergo various heart tests to monitor their condition. It's important to note that some individuals with specific heart and health issues, such as severe coronary artery disease or certain heart valve problems, may not be able to participate in this trial.

Gender

ALL

Eligibility criteria

• 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