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Clinical Trials in Italy / NCT06356727
Recruiting Not applicable

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

NCT06356727 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-01-03
Last updated
2024-04-10

Condition(s) studied

Heart FailureLeft Ventricular DysfunctionIdiopathic Dilated Cardiomyopathy

Investigational drug(s) / intervention(s)

Thermodilution based assessment of coronary microcirculation

Thermodilution based assessment of coronary microcirculation: Coronary microvascular assessment with the derivation of CFR, IMR and MRR will be performed using a standard pressure/thermodilution guidewire.

Study 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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Azienda Ospedaliera Universitaria di Ferrara Ferrara Italy Not Yet Recruiting
Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino Genova Italy Not Yet Recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele Milan Italy Not Yet Recruiting
Ospedale Galeazzi di Sant'Ambrogio IRCCS Milan Italy Not Yet Recruiting
University of Naples Federico II Naples Italy Not Yet Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy Not Yet Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea Rome Italy Not Yet Recruiting
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Torino Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria di Verona Verona Italy Recruiting

More Azienda Ospedaliera Universitaria Integrata Verona trials in Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06356727 on ClinicalTrials.gov ↗ ← All trials in Italy