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New treatment option for Heart Failure
Official title Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling
ClinicalTrials.gov ID: NCT06356727
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Willing and able to give informed consent for participation in the study
You likely can't join if
- Obstructive CAD (defined as angiographically intermediate disease [50%-70%] with impaired FFR or as angiographically severe disease [\>70%] in 1 or...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ferrara, Italy
- Genova, Italy
- Milan, Italy
- Naples, Italy
- Roma, Italy
- Rome, Italy
- Torino, Italy
- Verona, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ferrara, Italy; Genova, Italy; Milan, Italy; Naples, Italy; Roma, Italy; Rome, Italy and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.