The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
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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: Exercise hemodynamic test.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction, Chronic Pulmonary Thromboembolism (Disorder). 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 →
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Official title
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
Overview
To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.
Detailed description
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.
Interventions
- Diagnostic test Exercise hemodynamic test
Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography
Primary outcome measures
- Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg [Time frame: during the procedure]
Secondary outcome measures (12)
- Proportion of exercise induced pulmonary hypertension > 30 mmHg [Time frame: during the procedure]
- Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography [Time frame: during the procedure]
- Ventilatory mechanics [Time frame: during the procedure]
- Aerobic capacity [Time frame: during the procedure]
- coronary flow reserve [Time frame: during the procedure]
- index of microcirculatory resistance [Time frame: during the procedure]
- Lactate level at peak exercise [Time frame: during the procedure]
- LA stiffness [Time frame: during the procedure]
- change of E/e' between at rest and peak exercise [Time frame: between at rest and peak exercise]
- Rates of rehospitalization due to heart failure [Time frame: 5 years follow-up]
- Rates of all-cause death [Time frame: 5 years follow-up]
- The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise [Time frame: between at rest and peak exercise]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
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: NCT05490901 · EX_CATH