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

Samsung Medical Center

Status: Enrolling

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

Treatments: Diagnostic Test: Exercise hemodynamic test

Study type: Observational

Funder types: Other

Identifiers

NCT05490901

EX_CATH

Details and patient eligibility

About

To evaluate the role of exercise hemodynamic testing in the diagnostic workup for patients with dyspnea on exertion referred to the catheterization lab.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 1 patient group

Patients with Unexplained Dyspnea

Description:

Patients with dyspnea on exertion

Treatment:

Diagnostic Test: Exercise hemodynamic test