Clinical trial NCT05490901: The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Preserved Ejection Fraction
Chronic Pulmonary Thromboembolism (Disorder)
Keywords: Exercise hemodynamic test
Heart failure with preserved ejection fraction
Cardiac catheterization
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with dyspnea on exertion who undergo right heart catheterization and echocardiography during exercise due to clinical reasons.

Brief summary: 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.

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

Primary outcomes:
measure: Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg
timeFrame: during the procedure
Secondary outcomes:
measure: Proportion of exercise induced pulmonary hypertension > 30 mmHg
timeFrame: during the procedure
measure: Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
timeFrame: during the procedure
measure: Ventilatory mechanics
timeFrame: during the procedure
measure: Aerobic capacity
timeFrame: during the procedure
measure: coronary flow reserve
timeFrame: during the procedure
measure: index of microcirculatory resistance
timeFrame: during the procedure
measure: Lactate level at peak exercise
timeFrame: during the procedure
measure: LA stiffness
timeFrame: during the procedure
measure: change of E/e' between at rest and peak exercise
timeFrame: between at rest and peak exercise
measure: Rates of rehospitalization due to heart failure
timeFrame: 5 years follow-up
measure: Rates of all-cause death
timeFrame: 5 years follow-up
measure: The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise
timeFrame: between at rest and peak exercise
measure: change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise
timeFrame: between at rest and peak exercise
measure: change of S' between at rest and peak exercise
timeFrame: between at rest and peak exercise
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong Hoon Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: