Assessing microvascular dysfunction to improve heart failure treatment
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
NA · Azienda Ospedaliera Universitaria Integrata Verona · NCT06356727
This study is testing if a new way to check blood flow in the heart can help improve treatment for people with heart failure caused by idiopathic dilated cardiomyopathy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona (other) |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Ferrara and 8 other locations) |
| Trial ID | NCT06356727 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with idiopathic dilated cardiomyopathy and left ventricular dysfunction who have not yet received anti-remodeling cardiac therapy. Participants will undergo invasive assessments of coronary microvascular function using thermodilution techniques, followed by optimal medical therapy for 12 months. The primary goal is to evaluate left ventricular reverse remodeling through echocardiography after treatment. The study will also monitor patients' clinical status over a five-year period, utilizing various diagnostic tests to gather comprehensive data.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a first diagnosis of idiopathic dilated cardiomyopathy and left ventricular ejection fraction of 40% or less.
Not a fit: Patients with obstructive coronary artery disease or a history of significant cardiac events such as myocardial infarction or valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment strategies for heart failure patients, enhancing their heart function and overall health.
How similar studies have performed: While this approach is innovative, similar studies assessing microvascular function in heart failure have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ferrara and 8 other locations
- 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)
Study contacts
- Principal investigator: Roberto Scarsini, MD PhD — Azienda Ospedaliera Universitaria di Verona
- Study coordinator: Natascia Antonioli
- Email: studi.clinici.cardiologia@aovr.veneto.it
- Phone: 0039 0458122320
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Left Ventricular Dysfunction, Idiopathic Dilated Cardiomyopathy, coronary microvascular dysfunction, heart failure, left ventricular reverse remodeling, optimal medical therapy