The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
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: Exercise hemodynamic test.
- Кому может быть актуально
- Состояния в реестре: Heart Failure With Preserved Ejection Fraction, Chronic Pulmonary Thromboembolism (Disorder). 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
A Retrospective and Prospective Cohort Study to Investigate the Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
Обзор
To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.
Подробное описание
Heart failure with preserved ejection fraction (HFpEF) is a major public health problem that has no proven effective treatment. However, in practice, it's difficult to recognize early stage of HFpEF by resting hemodynamic study and echocardiography because the patients mainly complaint of dyspnea only during exercise but not resting condition. Accordingly, exercise stress test will be helpful to provide more information on pathophysiology, diagnosis, and severity in various cardiovascular diseases such as HFpEF, valvular heart disease, and chronic thromboembolic pulmonary hypertension. Thus, the broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance. Specifically, this study will compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.
Вмешательства
- Диагностический тест Exercise hemodynamic test
Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography
Первичные конечные точки
- Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg [Срок оценки: during the procedure]
Вторичные конечные точки (12)
- Proportion of exercise induced pulmonary hypertension > 30 mmHg [Срок оценки: during the procedure]
- Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography [Срок оценки: during the procedure]
- Ventilatory mechanics [Срок оценки: during the procedure]
- Aerobic capacity [Срок оценки: during the procedure]
- coronary flow reserve [Срок оценки: during the procedure]
- index of microcirculatory resistance [Срок оценки: during the procedure]
- Lactate level at peak exercise [Срок оценки: during the procedure]
- LA stiffness [Срок оценки: during the procedure]
- change of E/e' between at rest and peak exercise [Срок оценки: between at rest and peak exercise]
- Rates of rehospitalization due to heart failure [Срок оценки: 5 years follow-up]
- Rates of all-cause death [Срок оценки: 5 years follow-up]
- The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise [Срок оценки: between at rest and peak exercise]
Критерии участия
Критерии включения
- Subject must be at least 19 years of age.
- Patients with dyspnea on exertion
- Written informed consent of participating subjects after being fully briefed (for prospective analysis)
Критерии исключения
- Patients with incomplete hemodynamic data at rest or exercise
- Advanced tumor disease or other diseases with a short life expectancy
- Uncontrolled systemic arterial hypertension ( > 160/100 mmHg at rest)
- FEV1<50% predicted
- TLC<60% predicted
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: NCT05490901 · EX_CATH