The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Heart Failure With Preserved Ejection Fraction, Chronic Pulmonary Thromboembolism (Disorder)

Intervention / Treatment
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* Diagnostic Test: Exercise hemodynamic test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Unexplained Dyspnea<br>Patients with dyspnea on exertion | Diagnostic Test: Exercise hemodynamic test<br>* Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography<br>* Other names: Exercise cath;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg | Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP | during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of exercise induced pulmonary hypertension > 30 mmHg | Number of Participants with Diagnosis of pulmonary hypertension based on mean pulmonary pressure at peak exercise | during the procedure | 
| Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography | Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography | during the procedure | 
| Ventilatory mechanics | ratio of minute ventilation to carbon dioxide production (VE/VCO2) | during the procedure | 
| Aerobic capacity | peak oxygen consumption (VO2) | during the procedure | 
| coronary flow reserve | invasively measured coronary flow reserve | during the procedure | 
| index of microcirculatory resistance | invasively measured index of microcirculatory resistance | during the procedure | 
| Lactate level at peak exercise | Serum lactate level at peak exercise | during the procedure | 
| LA stiffness | LA stiffness measured by LA strain/E/e' using Transthoracic echocardiography | during the procedure | 
| change of E/e' between at rest and peak exercise | The change of E/e' between at rest and peak exercise | between at rest and peak exercise | 
| Rates of rehospitalization due to heart failure | Rehospitalization due to heart failure | 5 years follow-up | 
| Rates of all-cause death | Follow-up death | 5 years follow-up | 
| The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise | The change of 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 | The change of TAPSE between at rest and peak exercise | between at rest and peak exercise | 
| change of S' between at rest and peak exercise | The change of S' between at rest and peak exercise | between at rest and peak exercise | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise hemodynamic test, Heart failure with preserved ejection fraction, Cardiac catheterization