Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-01-08 @ 9:32 PM
Study NCT ID:
NCT05935605
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Hypertension in Left Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Exercise Cardiac Output', 'timeFrame': 'Baseline', 'description': 'Peak exercise cardiac output (L/min) will be measured using the direct Fick technique during the invasive hemodynamic assessment by right heart catheterization.'}, {'measure': 'Peak Exercise Oxygen Consumption (VO2)', 'timeFrame': 'Baseline', 'description': 'Peak exercise VO2 (ml/kg/min) will be measured using expired gas analysis collected during the invasive hemodynamic assessment by right heart catheterization.'}], 'secondaryOutcomes': [{'measure': 'Right Ventricular function assessed by Tricuspid Annular Plane Systolic Excursion (TAPSE)', 'timeFrame': 'Baseline', 'description': '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.'}, {'measure': 'Right Ventricular function assessed by tricuspid annular plane systolic excursion (TAPSE)/systolic pulmonary artery pressure (PASP) ratio', 'timeFrame': 'Baseline', 'description': 'TAPSE/PASP ratio (mm/mmHg) will be measured using transthoracic echocardiography during the invasive hemodynamic assessment by right heart catheterization.'}, {'measure': 'Extravascular Lung Fluid Content (B-line score)', 'timeFrame': 'Baseline', 'description': 'Extravascular Lung Fluid Content (B-line score) will be measured using lung ultrasound during the invasive hemodynamic assessment by right heart catheterization.'}, {'measure': 'Peripheral venous pressure', 'timeFrame': 'Baseline', 'description': '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)'}, {'measure': 'Right Arterial Pressure (RA) in the upright position', 'timeFrame': 'Baseline', 'description': 'Right Atrial (RA) pressure will be measured during the invasive hemodynamic assessment by right heart catheterization.'}, {'measure': 'Central pressures (RA, PA, and PCWP) in the upright position', 'timeFrame': 'Baseline', 'description': '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Pulmonary Vascular Disease', 'Left Heart Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the cardiac catheterization laboratory for invasive right heart catheterization for any reason.\n* Left Heart Disease, defined as one (or more) of the following:\n\n * 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.\n * Symptomatic HFrEF, defined by defined by signs and symptoms of HF (dyspnea, fatigue) and reduced EF (\\<50%).\n * 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).\n\nExclusion Criteria:\n\n* 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.\n* WSPH Group 1 Pulmonary hypertension or PH (Pulmonary arterial hypertension; including congenital heart disease)\n* Group 3 PH (Hypoxia/Lung disease-related PH)\n* Group 4 PH (Thromboembolic PH)\n* Group 5 PH (Miscellaneous)\n* Clinically significant parenchymal lung disease, hypoxemia, or lung infection\n* Amyloid/infiltrative cardiomyopathy\n* Acute Myocarditis\n* Acute coronary syndrome or revascularization within 90 days\n* Use of PH-specific drugs\n* Constrictive pericarditis\n* High output heart failure\n* HF hospitalization within the preceding 30 days\n* Severe or greater aortic (AVA \\< 1.0 cm2, Mean Gradient \\> 40 mmHg) or severe mitral (MVA \\< 1.0 cm) stenosis\n* Inability or unwillingness to exercise\n* Inadequate echocardiographic imaging windows\n* Inability or unwillingness to cooperate with breath holding'}, 'identificationModule': {'nctId': 'NCT05935605', 'briefTitle': 'Pulmonary Hypertension in Left Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparison of Noninvasively-Obtained Echocardiographic Doppler Parameters With Simultaneously-Measured Invasive Hemodynamics in Patients Referred for Right Heart Catheterization', 'orgStudyIdInfo': {'id': '17-008263'}, 'secondaryIdInfos': [{'id': '1R01HL162828-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL162828-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'LHD with no PH', 'description': '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.', 'interventionNames': ['Diagnostic Test: Transthoracic Echocardiography (TTE)', 'Diagnostic Test: Lung ultrasound']}, {'label': 'LHD with isolated PVH', 'description': '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.', 'interventionNames': ['Diagnostic Test: Transthoracic Echocardiography (TTE)', 'Diagnostic Test: Lung ultrasound']}, {'label': 'LHD with vasoactive PVD', 'description': '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.', 'interventionNames': ['Diagnostic Test: Transthoracic Echocardiography (TTE)', 'Diagnostic Test: Lung ultrasound']}, {'label': 'LHD with fixed PVD', 'description': '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.', 'interventionNames': ['Diagnostic Test: Transthoracic Echocardiography (TTE)', 'Diagnostic Test: Lung ultrasound']}], 'interventions': [{'name': 'Transthoracic Echocardiography (TTE)', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LHD with fixed PVD', 'LHD with isolated PVH', 'LHD with no PH', 'LHD with vasoactive PVD']}, {'name': 'Lung ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['LHD with fixed PVD', 'LHD with isolated PVH', 'LHD with no PH', 'LHD with vasoactive PVD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Circulatory Failure Research Team', 'role': 'CONTACT', 'phone': '(507) 255-2200'}, {'name': 'Barry Borlaug, MD', 'role': 'CONTACT', 'email': 'Borlaug.Barry@mayo.edu', 'phone': '(507) 255-4152'}, {'name': 'Barry Borlaug, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Circulatory Failure Research Team', 'role': 'CONTACT', 'phone': '(507) 255-2200'}, {'name': 'Barry Borlaug, MD', 'role': 'CONTACT', 'email': 'Borlaug.Barry@mayo.edu', 'phone': '(507) 255-4152'}], 'overallOfficials': [{'name': 'Barry Borlaug, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barry Borlaug', 'investigatorAffiliation': 'Mayo Clinic'}}}}