NCT06356727Active, not recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 30 Mar 2024
- Start date
- 3 Jan 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Diseases
- Heart failure
- NCT number
- NCT06356727
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 3 Jan 2024 to the primary completion date, 1 Sept 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous myocardial infarction, percutaneous revascularization or coronary-aortic bypass graft (CABG) surgery
Other illness
- Obstructive CAD (defined as angiographically intermediate disease \[50%-70%\] with impaired FFR or as angiographically severe disease \[\>70%\] in 1 or more epicardial vessels)
- Valvular heart disease (rheumatic heart disease, severe aortic stenosis, severe aortic regurgitation, severe primary mitral regurgitation)
- Congenital heart disease
- Persistent tachyarrhythmias (documented persistent high-rate supraventricular arrhythmias)
- History of chemotherapy (anthracycline therapy, cumulative dosages \>250 mg/m2)
- History of uncontrolled arterial hypertension (blood pressure \>160/100 mmHg)
- Allergy or other contraindication to iodinated contrast and/or adenosine
Lab values
- Stage IV and V of chronic kidney disease (eGFR \< 30 ml/min, estimated through CKD - EPI Creatinine Equation)
Other
- Infective endocarditis
- Peripartum cardiomyopathy
- Acute myocarditis (detected by endomyocardial biopsy - histological criteria - or by CMR - Lake Louis criteria) and pericarditis
- Excessive alcohol intake (\>80 g/die for at least five years)
- Chronic resting O2 saturation \<85%
- Pregnancy or suspected pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UOC Cardiologia, PO di Conegliano Coordinator of this site? Confirm its status | Conegliano | Italy | Unknown status |
| Università della Calabria Coordinator of this site? Confirm its status | Cosenza | Italy | Unknown status |
| Azienda Ospedaliera Universitaria di Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Ospedale Galeazzi di Sant'Ambrogio IRCCS Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| University of Naples Federico II Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Sant'Andrea Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Azienda Ospedaliera Universitaria di Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.