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NCT Number: NCT05490901

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise hemodynamic test

Diagnostic Test

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

Other names: Exercise cath

Primary outcomes

  1. Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg

    Time frame: during the procedure

    Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP

Secondary outcomes

  1. Proportion of exercise induced pulmonary hypertension > 30 mmHg

    Time frame: during the procedure

    Number of Participants with Diagnosis of pulmonary hypertension based on mean pulmonary pressure at peak exercise

  2. Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography

    Time frame: during the procedure

    Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography

  3. Ventilatory mechanics

    Time frame: during the procedure

    ratio of minute ventilation to carbon dioxide production (VE/VCO2)

  4. Aerobic capacity

    Time frame: during the procedure

    peak oxygen consumption (VO2)

  5. coronary flow reserve

    Time frame: during the procedure

    invasively measured coronary flow reserve

  6. index of microcirculatory resistance

    Time frame: during the procedure

    invasively measured index of microcirculatory resistance

  7. Lactate level at peak exercise

    Time frame: during the procedure

    Serum lactate level at peak exercise

  8. LA stiffness

    Time frame: during the procedure

    LA stiffness measured by LA strain/E/e' using Transthoracic echocardiography

  9. change of E/e' between at rest and peak exercise

    Time frame: between at rest and peak exercise

    The change of E/e' between at rest and peak exercise

  10. Rates of rehospitalization due to heart failure

    Time frame: 5 years follow-up

    Rehospitalization due to heart failure

  11. Rates of all-cause death

    Time frame: 5 years follow-up

    Follow-up death

  12. The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise

    Time frame: between at rest and peak exercise

    The change of RVSP between at rest and peak exercise

  13. change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise

    Time frame: between at rest and peak exercise

    The change of TAPSE between at rest and peak exercise

  14. change of S' between at rest and peak exercise

    Time frame: between at rest and peak exercise

    The change of S' between at rest and peak exercise

Study contacts

Contact information is provided by the study sponsor or research team.

Jeong Hoon Yang, MD

CONTACT

[email protected]

82-2-3410-3419

Ki Hong Choi, MD

CONTACT

[email protected]

82-2-3410-6653

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Acronym: EX_CATH

Important dates

Study start
2020
Primary completion
2028
Study completion
2029
First posted
Aug 8, 2022
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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