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
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CMD test.
- Кому может быть актуально
- Состояния в реестре: Heart Failure, Microvascular Angina, Non-ischemic Cardiomyopathy. Базовые параметры: от 19 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- South Korea
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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).
Обзор
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.
Подробное описание
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.
Вмешательства
- Диагностический тест CMD test
Measured CFR and IMR
Первичные конечные точки
- Proportion of HFiEF* at 12 months [Срок оценки: 1-year follow-up]
Вторичные конечные точки (12)
- Correlation between CMD and left ventricular end diastolic pressure [Срок оценки: 1 year]
- Correlation between CMD and delta LVEF from baseline to 12 months [Срок оценки: 1 year]
- Correlation between CMD and E/e' [Срок оценки: 1 year]
- Correlation between CMD and delta LV systolic dimension from baseline to 12 months [Срок оценки: 1 year]
- Correlation between CMD and delta LV diastolic dimension from baseline to 12 months [Срок оценки: 1-year follow-up]
- Correlation between CMD and late gadolinium enhancement measured by cardiac MRI [Срок оценки: 1 year]
- Correlation between CMD and pulmonary artery wedge pressure [Срок оценки: 1 year]
- Correlation between CMD and mean pulmonary artery pressure [Срок оценки: 1 year]
- Correlation between CMD and pulmonary artery pulsatility index (PAPi) [Срок оценки: 1 year]
- Correlation between CMD and cardiac output/cardiac index [Срок оценки: 1 year]
- Correlation between CMD and delta NT-proBNP from baseline to 12 months follow-up [Срок оценки: 1-year follow-up]
- Proportion of CMD according to etiology [Срок оценки: 1 year]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
South Korea · 1 центр
- Samsung Medical Center — Seoul
Идентификаторы
NCT: NCT06243653 · HFrEF-CMD