The Prognostic Role and Diagnostic Efficacy of Exercise Right Heart Catheterization With a Simultaneous Echocardiography in Patients With Dyspnea on Exertion
- Conditions
- Heart Failure With Preserved Ejection FractionChronic Pulmonary Thromboembolism (Disorder)
- Interventions
- Diagnostic Test: Exercise hemodynamic test
- Registration Number
- NCT05490901
- Lead Sponsor
- Samsung Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Unexplained Dyspnea Exercise hemodynamic test Patients with dyspnea on exertion
- Primary Outcome Measures
Name Time Method Proportion of exercise induced pulmonary artery wedge pressure >25 mmHg during the procedure Number of Participants with Diagnosis of earlier heart failure with preserved ejection fraction based on exercise PCWP
- Secondary Outcome Measures
Name Time Method Lactate level at peak exercise during the procedure Serum lactate level at peak exercise
LA stiffness during the procedure LA stiffness measured by LA strain/E/e' using Transthoracic echocardiography
coronary flow reserve during the procedure invasively measured coronary flow reserve
Proportion of exercise induced pulmonary hypertension > 30 mmHg during the procedure Number of Participants with Diagnosis of pulmonary hypertension based on mean pulmonary pressure at peak exercise
Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography during the procedure Correlation between peripheral venous pressure and right atrial pressure assumed by echocardiography
Ventilatory mechanics during the procedure ratio of minute ventilation to carbon dioxide production (VE/VCO2)
Aerobic capacity during the procedure peak oxygen consumption (VO2)
index of microcirculatory resistance during the procedure invasively measured index of microcirculatory resistance
change of E/e' between at rest and peak exercise between at rest and peak exercise The change of E/e' between at rest and peak exercise
Rates of rehospitalization due to heart failure 5 years follow-up Rehospitalization due to heart failure
The change of right ventricular systolic pressure (RVSP) between at rest and peak exercise between at rest and peak exercise The change of RVSP between at rest and peak exercise
change of Tricuspid annular plane systolic excursion (TAPSE) between at rest and peak exercise between at rest and peak exercise The change of TAPSE between at rest and peak exercise
change of S' between at rest and peak exercise between at rest and peak exercise The change of S' between at rest and peak exercise
Rates of all-cause death 5 years follow-up Follow-up death
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of