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

Heart Failure With Preserved Ejection Fraction Clinical Trial

— EX_CATH  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05490901
• Other study ID #: EX_CATH
• Status: Recruiting
• Start date: March 17, 2020
• Est. completion date: June 30, 2029

Study information

• Verified date: August 2022
• Source: Samsung Medical Center
• Contact: Jeong Hoon Yang, MD
• Phone: 82-2-3410-3419
• Email: jhysmc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Pulmonary Embolism
• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Ventilatory mechanics	ratio of minute ventilation to carbon dioxide production (VE/VCO2)	during the procedure
Secondary	Aerobic capacity	peak oxygen consumption (VO2)	during the procedure
Secondary	coronary flow reserve	invasively measured coronary flow reserve	during the procedure
Secondary	index of microcirculatory resistance	invasively measured index of microcirculatory resistance	during the procedure
Secondary	Lactate level at peak exercise	Serum lactate level at peak exercise	during the procedure
Secondary	LA stiffness	LA stiffness measured by LA strain/E/e' using Transthoracic echocardiography	during the procedure
Secondary	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
Secondary	Rates of rehospitalization due to heart failure	Rehospitalization due to heart failure	5 years follow-up
Secondary	Rates of all-cause death	Follow-up death	5 years follow-up
Secondary	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
Secondary	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
Secondary	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