Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-25 @ 3:38 PM
Study NCT ID:
NCT06195059
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Vascular Capacitance at Rest', 'timeFrame': 'Baseline', 'description': 'Capacitance is defined as the total volume of blood in an organ or region at a given pressure. Pulmonary Vascular Capacitance (ml/mmHg) will be determined by pulmonary blood volume/mean pulmonary artery pressure as measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Vascular Capacitance During Exercise', 'timeFrame': 'Baseline', 'description': 'Capacitance is defined as the total volume of blood in an organ or region at a given pressure. Pulmonary Vascular Capacitance (ml/mmHg) will be determined by pulmonary blood volume/mean pulmonary artery pressure as measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Blood Volume at Rest', 'timeFrame': 'Baseline', 'description': 'Pulmonary blood volume (ml) is measured by measuring indicator dilution curves using sonographic contrast at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Blood Volume During Exercise', 'timeFrame': 'Baseline', 'description': 'Pulmonary blood volume (ml) is measured by measuring indicator dilution curves using sonographic contrast during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Vascular Compliance at Rest', 'timeFrame': 'Baseline', 'description': 'Compliance is the change in volume for a given change in pressure. Pulmonary Vascular Compliance (ml/mmHg) is defined as stroke volume divided by Pulmonary Artery (PA) pulse pressure and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Vascular Compliance During Exercise', 'timeFrame': 'Baseline', 'description': 'Compliance is the change in volume for a given change in pressure. Pulmonary Vascular Compliance (ml/mmHg) is defined as stroke volume divided by Pulmonary Artery (PA) pulse pressure and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Right Atrial Pressure at Rest', 'timeFrame': 'Baseline', 'description': 'Right Atrial Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Right Atrial Pressure During Exercise', 'timeFrame': 'Baseline', 'description': 'Right Atrial Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Right Ventricular Pressure at Rest', 'timeFrame': 'Baseline', 'description': 'Right Ventricular Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Right Ventricular Pressure During Exercise', 'timeFrame': 'Baseline', 'description': 'Right Ventricular Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Artery Pressure at Rest', 'timeFrame': 'Baseline', 'description': 'Pulmonary Artery Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Artery Pressure During Exercise', 'timeFrame': 'Baseline', 'description': 'Pulmonary Artery Pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Capillary Wedge Pressure at Rest', 'timeFrame': 'Baseline', 'description': 'Pulmonary capillary wedge pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Capillary Wedge Pressure During Exercise', 'timeFrame': 'Baseline', 'description': 'Pulmonary capillary wedge pressure (mmHg) is a measure of cardiac filling pressure, measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Cardiac Output at Rest', 'timeFrame': 'Baseline', 'description': 'Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Cardiac Output During Exercise', 'timeFrame': 'Baseline', 'description': 'Cardiac output (L/min) is the total volume of blood moved by the heart per minute and will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Vascular Resistance at Rest', 'timeFrame': 'Baseline', 'description': 'Pulmonary vascular resistance (PVR) is the resistance against blood flow from the pulmonary artery to the left atrium. PVR (in Wood units) will be measured with high fidelity micromanometer catheters in the pulmonary vasculature at rest during the standard of care exercise hemodynamic assessment.'}, {'measure': 'Pulmonary Vascular Resistance During Exercise', 'timeFrame': 'Baseline', 'description': 'Pulmonary vascular resistance (PVR) is the resistance against blood flow from the pulmonary artery to the left atrium. PVR (in Wood units) will be measured with high fidelity micromanometer catheters in the pulmonary vasculature during the exercise portion of the standard of care exercise hemodynamic assessment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Pulmonary Vascular Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether pulmonary blood volume (PBV) derived from contrast echocardiography can serve as a non-invasive surrogate for invasive pulmonary artery wedge pressure (PAWP) during exercise. Also, to compare changes in PBV with exercise in patients with and without heart failure and pulmonary vascular disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have already been referred to the catheterization laboratory at Mayo Clinic in Rochester, MN for the exercise hemodynamic assessment will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to the cardiac catheterization laboratory for invasive exercise right heart catheterization for evaluating exertional dyspnea. Investigators will include patients with normal or low EF, and across the spectrum of pulmonary hypertension severity.\n\nExclusion Criteria:\n\n* Patient inability or unwillingness to undergo echocardiography including a contrast method, or if echocardiography would, in the opinion of the investigator, somehow compromise the quality of data acquisition for the clinical case.\n* Prior adverse reaction to echo contrast administration'}, 'identificationModule': {'nctId': 'NCT06195059', 'briefTitle': 'Contrast Echocardiography During Exercise to Assess Pulmonary Blood Volume', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Assessment of Pulmonary Blood Volume Using Contrast Echocardiography During Exercise', 'orgStudyIdInfo': {'id': '23-009478'}}, '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': '507-255-2142'}, {'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': '507-255-2142'}], 'overallOfficials': [{'name': 'Barry Borlaug, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Barry Borlaug', 'investigatorAffiliation': 'Mayo Clinic'}}}}