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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg
研究概览
简要总结
To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg
时间窗: during the procedure
Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP
次要结局
- Lactate level at peak exercise(during the procedure)
- LA stiffness(during the procedure)
- coronary flow reserve(during the procedure)
- Proportion of exercise induced pulmonary hypertension > 30 mmHg(during the procedure)
- Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography(during the procedure)
- Ventilatory mechanics(during the procedure)
- Aerobic capacity(during the procedure)
- index of microcirculatory resistance(during the procedure)
- change of E/e' between at rest and peak exercise(between at rest and peak exercise)
- Rates of rehospitalization due to heart failure(5 years follow-up)
- The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise(between at rest and peak exercise)
- change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise(between at rest and peak exercise)
- change of S' between at rest and peak exercise(between at rest and peak exercise)
- Rates of all-cause death(5 years follow-up)
研究者
Jeong Hoon Yang
Professor
Samsung Medical Center