RecruitingNot ApplicableNCT06356727

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy


Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Enrollment

190 participants

Start Date

Jan 3, 2024

Study Type

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

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether measuring how well the tiny blood vessels in the heart work (microvascular function) can predict which patients with a weakened heart (dilated cardiomyopathy) will improve their heart's pumping ability after treatment. Currently it's hard to predict who will recover — this test could help. **You may be eligible if...** - You are 18 or older (any gender) - You have been newly diagnosed with dilated cardiomyopathy (a weakened, enlarged heart) with a reduced pumping strength (ejection fraction of 40% or less) - Your doctors have recommended coronary angiography (a heart artery imaging test) to rule out blockages - You are willing and able to give informed consent **You may NOT be eligible if...** - You have significant blockages in your heart arteries - You have had a previous heart attack, stent placement, or bypass surgery - You have significant valve disease (such as severe aortic stenosis or mitral regurgitation) - You have had a heart infection, inflammation (myocarditis), or congenital heart disease - You have severely reduced kidney function or a contrast dye allergy - You drink more than 80 grams of alcohol per day - You have received high-dose chemotherapy (anthracyclines) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTThermodilution 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.


Locations(9)

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

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NCT06356727


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