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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL162828-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transthoracic Echocardiography (TTE) | Diagnostic Test | Transthoracic echocardiography using ultrasound waves will be conducted during the rest and exercise phases of the clinically indicated invasive hemodynamic assessment by right heart catheterization to gather additional measurements of right ventricular function. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Exercise Cardiac Output | Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization. | Baseline |
| Peak Exercise Oxygen Consumption (VO2) | Peak exercise VO2 (ml/kg/min) will be measured using expired gas analysis collected during the invasive hemodynamic assessment by right heart catheterization. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE) | TAPSE is measured as the displacement (in mm) of the lateral tricuspid annulus toward the apex during systole measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization. | Baseline |
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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:
Exclusion Criteria:
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Patients with known or suspected Left Heart Disease (LHD) that are already referred for invasive hemodynamic assessment by right heart catheterization for clinical reasons at Mayo Clinic in Rochester, MN will be identified and approached for participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Circulatory Failure Research Team | Contact | (507) 255-2200 | Fuenffinger.Annabelle@mayo.edu | |
| Barry Borlaug, MD | Contact | (507) 255-4152 | Borlaug.Barry@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Barry Borlaug, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples from the pulmonary artery and systemic artery will be collected at rest & during exercise portion of the cardiac catheterization procedure in EDTA tubes & stored for future discovery-based analyses.
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| Lung ultrasound | Diagnostic Test | A lung ultrasound, which uses sound waves to produce images of the lungs, will be used to assess extravascular lung fluid during the rest and exercise phases of the clinically indicated invasive hemodynamic assessment by right heart catheterization. |
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| Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio |
TAPSE/PASP ratio (mm/mmHg) will be measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization. |
| Baseline |
| Extravascular Lung Fluid Content (B-line score) | Extravascular Lung Fluid Content (B-line score) will be measured using lung ultrasound during the invasive hemodynamic assessment by right heart catheterization. | Baseline |
| Peripheral venous pressure | Peripheral venous pressure will be measured through a standard upper extremity peripheral IV line. Peripheral venous pressure (PVP) is reported in millimeters of mercury (mmHg) | Baseline |
| Right Arterial Pressure (RA) in the upright position | Right Atrial (RA) pressure will be measured during the invasive hemodynamic assessment by right heart catheterization. | Baseline |
| Central pressures (RA, PA, and PCWP) in the upright position | The same pressures that are measured in the supine position will be measured in the upright position in a subset of patients. These measures will be obtained at rest and during exercise (for those receiving this). | Baseline |
| D002318 |
| Cardiovascular Diseases |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |