Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling in Idiopathic Dilated Cardiomyopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 190
- Locations
- 9
- Primary Endpoint
- Rate of Left ventricular reverse remodeling (LVRR)
Study Overview
Brief 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.
Detailed Description
This is a prospective, multicentric, single-arm explorative clinical study in patients presenting with heart failure and idiopathic dilated cardiomyopathy with LVEF ≤ 40%. Patients identified as eligible for the protocol will be asked for written informed consent to participate in the study.
After appropriate treatment of the acute heart failure phase, participants will undergo coronary angiography to rule out obstructive coronary disease.
Fractional flow reserve (FFR) will be assessed as per standard clinical practice and a value ≤ 0.80 will be considered abnormal. Microvascular assessment will be performed using the same pressure/thermodilution guidewire used for FFR assessment with the derivation of coronary flow reserve (CFR), index of microcirculatory resistance (IMR) and the microvascular resistance reserve (MRR).
Steady-state hyperemia will be obtained using an intravenous adenosine infusion or intracoronary papaverine as per routine clinical practice.
The primary endpoint will be assessed based on the variation of echocardiographic indices from the baseline to 12-month follow up. Transthoracic echocardiography will be performed to confirm the diagnosis and obtain information about adverse cardiac remodeling and after 12 months of optimal medical therapy to evaluate reverse remodeling.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Microvascular assessment
Coronary microvascular assessment
Intervention: Thermodilution based assessment of coronary microcirculation (Diagnostic Test)
Outcomes
Primary Outcomes
Rate of Left ventricular reverse remodeling (LVRR)
Time Frame: After 12 months of guidelines directed optimal medical therapy
LVRR, defined as LVEF increase ≥ 10% and LVEDDi decrease ≥ 10%, will be assessed with transthoracic echocardiography and analyzed off-line by an independent central corelab.
Secondary Outcomes
- Adverse clinical events(Up to 5 years)
- Rate of LVRR at cardiac magnetic resonance(After 12 months of guidelines directed OMT)
- Changes in functional capacity at cardiopulmonary exercise test(After 12 months of guidelines-defined OMT)
- Prevalence of different CMD endotypes and their correlation with the severity of adverse cardiac remodeling.(At baseline)
- Left ventricle adverse cardiac remodeling at cardiovascular magnetic resonance.(At baseline)
Investigators
Roberto Scarsini
Principal investigator
Azienda Ospedaliera Universitaria Integrata Verona