Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CMD test.
- Who it may be relevant to
- Registry conditions: Heart Failure, Microvascular Angina, Non-ischemic Cardiomyopathy. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Coronary Microvascular Dysfunction in Improving Left Ventricular Systolic Function Using Registry for Evaluation of Factors associatEd With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology (REFERENCE).
Overview
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.
Detailed description
HF is a clinical syndrome characterized by dyspnea or exertional limitation due to impairment of ventricular filling or ejection of blood or both. HFrEF occurs when the left ventricular ejection fraction (LVEF) is 40% or less and is accompanied by progressive left ventricular dilatation and adverse cardiac remodeling. Among them, a substantial portion of patients had non-ischemic etiology.4 The CMD, defined by impaired coronary flow reserve (CFR), is commonly observed in patients with cardiomyopathies caused by non-ischemic etiology and is well-known to be associated with poor prognosis independently of the degree of left ventricular functional abnormality. However, the presence of CMD can be more specifically evaluated by invasive physiologic assessment using both CFR and the index of microcirculatory resistance (IMR) than by non-invasive methods (doppler echocardiography, positron emission tomography, or cardiac magnetic resonance imaging \[MRI\]) measuring CFR alone. Considering that CMD, defined by depressed CFR with elevated IMR, reflects the impaired myocardial flow and microvascular damages, there was a possibility that it may be a predictor of irreversible myocardial damages in HFrEF patients with non-ischemic etiology. Nevertheless, there has been limited data regarding the association between the improvement of LV function and CMD for patients with HFrEF caused by non-ischemic etiology after guideline-directed medical treatment (GDMT). Therefore, the investigators sought to evaluate the incidence of CMD and its prognostic implication for the improvement of left ventricular function after GDMT in patients who have been diagnosed with HFrEF caused by non-ischemic etiology.
Interventions
- Diagnostic test CMD test
Measured CFR and IMR
Primary outcome measures
- Proportion of HFiEF* at 12 months [Time frame: 1-year follow-up]
Secondary outcome measures (12)
- Correlation between CMD and left ventricular end diastolic pressure [Time frame: 1 year]
- Correlation between CMD and delta LVEF from baseline to 12 months [Time frame: 1 year]
- Correlation between CMD and E/e' [Time frame: 1 year]
- Correlation between CMD and delta LV systolic dimension from baseline to 12 months [Time frame: 1 year]
- Correlation between CMD and delta LV diastolic dimension from baseline to 12 months [Time frame: 1-year follow-up]
- Correlation between CMD and late gadolinium enhancement measured by cardiac MRI [Time frame: 1 year]
- Correlation between CMD and pulmonary artery wedge pressure [Time frame: 1 year]
- Correlation between CMD and mean pulmonary artery pressure [Time frame: 1 year]
- Correlation between CMD and pulmonary artery pulsatility index (PAPi) [Time frame: 1 year]
- Correlation between CMD and cardiac output/cardiac index [Time frame: 1 year]
- Correlation between CMD and delta NT-proBNP from baseline to 12 months follow-up [Time frame: 1-year follow-up]
- Proportion of CMD according to etiology [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT06243653 · HFrEF-CMD