Comparison of Noninvasively-Obtained Echocardiographic Doppler Parameters With Simultaneously-Measured Invasive Hemodynamics in Patients Referred for Right Heart Catheterization
Overview
- Phase
- Not Applicable
- Intervention
- Transthoracic Echocardiography (TTE)
- Conditions
- Pulmonary Hypertension
- Sponsor
- Mayo Clinic
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Peak Exercise Cardiac Output
- Status
- Recruiting
- Last Updated
- last month
Overview
Brief Summary
The goal is to compare patients with and without varying severity of pulmonary vascular disease based upon hemodynamic signatures, echocardiographic measures, and lung ultrasound, in tandem with expired gas metabolic testing and blood sampling.
Investigators
Barry Borlaug
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Patients referred to the cardiac catheterization laboratory for invasive right heart catheterization for any reason.
- •Left Heart Disease, defined as one (or more) of the following:
- •Symptomatic HFpEF, defined by signs and symptoms of HF (dyspnea, fatigue), normal left ventricular (LV) EF (≥50% within 12 months of enrollment), and objective evidence of HF fulfilling at least one of the following criteria: Prior hospitalization for decompensated HF treated with intravenous diuretics; Invasively verified HFpEF defined by pulmonary capillary wedge pressure (PCWP) of ≥15 mmHg at rest and/or ≥25 mmHg during exercise; Clinical diagnosis of HFpEF that does not meet criteria i. or ii. but verified with NTproBNP\>300 pg/ml in sinus rhythm or \>900 pg/ml in AF; H2FPEF score ≥6 or HFA-PEFF score≥5 according to current guidelines.
- •Symptomatic HFrEF, defined by defined by signs and symptoms of HF (dyspnea, fatigue) and reduced EF (\<50%).
- •Symptomatic valvular heart disease (VHD), defined by signs and symptoms of HF (dyspnea, fatigue) in tandem with clinically significant aortic or mitral valve disease (regurgitation and/or stenosis).
Exclusion Criteria
- •Patient inability or unwillingness to undergo noninvasive echocardiography, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.
- •WSPH Group 1 Pulmonary hypertension or PH (Pulmonary arterial hypertension; including congenital heart disease)
- •Group 3 PH (Hypoxia/Lung disease-related PH)
- •Group 4 PH (Thromboembolic PH)
- •Group 5 PH (Miscellaneous)
- •Clinically significant parenchymal lung disease, hypoxemia, or lung infection
- •Amyloid/infiltrative cardiomyopathy
- •Acute Myocarditis
- •Acute coronary syndrome or revascularization within 90 days
- •Use of PH-specific drugs
Arms & Interventions
LHD with no PH
Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Transthoracic Echocardiography (TTE)
LHD with no PH
Subjects with Left Heart Disease (LHD) and no Pulmonary Hypertension (PH; mean pulmonary artery (PA) pressure ≤20 mmHg) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Lung ultrasound
LHD with isolated PVH
Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure\>20 mmHg and PVR\<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Transthoracic Echocardiography (TTE)
LHD with isolated PVH
Subjects with Left Heart Disease (LHD) and isolated Pulmonary Venous Hypertension (PVH; mean PA pressure\>20 mmHg and PVR\<3 WU) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Lung ultrasound
LHD with vasoactive PVD
Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Transthoracic Echocardiography (TTE)
LHD with vasoactive PVD
Subjects with Left Heart Disease (LHD) and vasoactive Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg and PVR≥3 WU with ≥20% reduction in PVR with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Lung ultrasound
LHD with fixed PVD
Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg, PVR≥3 WU, and PVR reduction of \<20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Transthoracic Echocardiography (TTE)
LHD with fixed PVD
Subjects with Left Heart Disease (LHD) and fixed Pulmonary Vascular Disease (PVD; mean PA pressure\>20 mmHg, PVR≥3 WU, and PVR reduction of \<20% with inhaled nitric oxide) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons will undergo transthoracic echocardiography and lung ultrasound.
Intervention: Lung ultrasound
Outcomes
Primary Outcomes
Peak Exercise Cardiac Output
Time Frame: Baseline
Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization.
Peak Exercise Oxygen Consumption (VO2)
Time Frame: Baseline
Peak exercise VO2 (ml/kg/min) will be measured using expired gas analysis collected during the invasive hemodynamic assessment by right heart catheterization.
Secondary Outcomes
- Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE)(Baseline)
- Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio(Baseline)
- Extravascular Lung Fluid Content (B-line score)(Baseline)
- Peripheral venous pressure(Baseline)
- Right Arterial Pressure (RA) in the upright position(Baseline)
- Central pressures (RA, PA, and PCWP) in the upright position(Baseline)