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

NCT ID: NCT05490901

Last Updated: 2022-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2029-06-30

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Unexplained Dyspnea

Patients with dyspnea on exertion

Exercise hemodynamic test

Intervention Type DIAGNOSTIC_TEST

Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography

Interventions

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Exercise hemodynamic test

Assessment of pulmonary hemodynamics during exercise by right heart catheterization and cardiac function during exercise by a simultaneous transthoracic echocardiography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Exercise cath

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jeong Hoon Yang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Hoon Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jeong Hoon Yang, MD

Role: CONTACT

82-2-3410-3419

Ki Hong Choi, MD

Role: CONTACT

82-2-3410-6653

Facility Contacts

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Jeong Hoon Yang, MD

Role: primary

82-2-3410-3419

Other Identifiers

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EX_CATH

Identifier Type: -

Identifier Source: org_study_id

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