About this trial
This study aims to evaluate the incidence of coronary microvascular dysfunction (CMD) and its prognostic implication for the improvement of left ventricular function in patients who have been diagnosed with heart failure with reduced ejection fraction (HFrEF) caused by non-ischemic etiology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a) Subject must be at least 19 years of age. b) Subject with symptoms or signs of HF (NYHA ≥2 dyspnea) and reduced ejection fraction (LVEF ≤ 40%) c) Subject who clinically need coronary angiography d) Subject who can voluntarily sign informed consent form
Disqualifiers
a) Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve [FFR] ≤0.80) b) Subject scheduled for cardiac replacement therapy (heart transplantation or left ventricular assisted device [LVAD] implantation) c) HF due to restrictive cardiomyopathy, active myocarditis, or constrictive pericarditis d) Significant valvular heart disease requiring surgery e) Subject who have non-cardiac co-morbid conditions with life expectancy <1 year
Trial population
Patients with heart failure with reduced ejection fraction (HFrEF) without significant coronary artery disease (non-ischemic cardiomyopathy)
Trial design
Cohort
Prospective
Treatments tested in this trial
CMD test
Diagnostic testMeasured CFR and IMR
Treatment groups
Trial outcomes
Primary outcomes
Proportion of HFiEF* at 12 months
HFiEF was defined as LVEF \>40% measured by echocardiography at 12 months.1
Secondary outcomes
Correlation between CMD and left ventricular end diastolic pressure
Correlation between CMD and delta LVEF from baseline to 12 months
Correlation between CMD and E/e'
Correlation between CMD and delta LV systolic dimension from baseline to 12 months
Sponsors and contacts
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