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

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

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

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Preserved Ejection Fraction; Chronic Pulmonary Thromboembolism (Disorder)
• Intervention / Treatment: Diagnostic test: Exercise hemodynamic test

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Ki Hong Choi, MD; Phone Number: 82-2-3410-6653; Email: cardiokh@gmail.com
• Study Contact Backup: Name: Jeong Hoon Yang, MD; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Jeong Hoon Yang, MD; Phone Number: 82-2-3410-3419; Email: jhysmc@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Unexplained Dyspnea; Patients with dyspnea on exertion	Diagnostic test: Exercise hemodynamic 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jeong Hoon Yang, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): June 30, 2029

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Heart failure with preserved ejection fraction; Cardiac catheterization; Exercise hemodynamic test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Embolism and Thrombosis; Signs and Symptoms, Respiratory; Embolism; Heart Failure; Thromboembolism; Pulmonary Embolism; Dyspnea
• Other Study ID Numbers: EX_CATH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No