Actively Recruiting
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2024-04-10
190
Participants Needed
9
Research Sites
317 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera Universitaria Integrata Verona
Lead Sponsor
A
Abbott Medical Devices
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, aged >18 years
- First diagnosis of idiopathic dilated cardiomyopathy with LVEF ≤ 40% and clinical indication for diagnostic coronary angiography
- Willing and able to give informed consent to participate in the study
You will not qualify if you...
- Obstructive coronary artery disease (50%-70% intermediate disease with impaired FFR or >70% severe disease in one or more epicardial vessels)
- History of myocardial infarction, percutaneous revascularization, or coronary artery bypass graft surgery
- Valvular heart disease including rheumatic heart disease, severe aortic stenosis, severe aortic regurgitation, severe primary mitral regurgitation
- Infective endocarditis
- Congenital heart disease
- Peripartum cardiomyopathy
- Acute myocarditis or pericarditis
- Persistent high-rate supraventricular arrhythmias
- Excessive alcohol intake over 80 g/day for at least five years
- History of chemotherapy with anthracycline therapy exceeding 250 mg/m2
- History of uncontrolled arterial hypertension (blood pressure >160/100 mmHg)
- Stage IV or V chronic kidney disease (eGFR < 30 ml/min)
- Allergy or contraindication to iodinated contrast or adenosine
- Chronic resting oxygen saturation below 85%
- Pregnancy or suspected pregnancy
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Italy
Not Yet Recruiting
2
Cardiothoracic and Vascular Department (DICATOV) IRCCS, Ospedale Policlinico San Martino
Genova, Italy
Not Yet Recruiting
3
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) dell'Ospedale San Raffaele
Milan, Italy
Not Yet Recruiting
4
Ospedale Galeazzi di Sant'Ambrogio IRCCS
Milan, Italy
Not Yet Recruiting
5
University of Naples Federico II
Naples, Italy
Not Yet Recruiting
6
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Not Yet Recruiting
7
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Italy
Not Yet Recruiting
8
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, Italy
Not Yet Recruiting
9
Azienda Ospedaliera Universitaria di Verona
Verona, Italy, 37126
Actively Recruiting
Research Team
N
Natascia Antonioli
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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