Ignite Creation Date:
2025-12-25 @ 4:47 AM
Ignite Modification Date:
2025-12-26 @ 3:49 AM
Study NCT ID:
NCT05665218
Status:
UNKNOWN
Last Update Posted:
2022-12-27
First Post:
2022-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-16', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-16', 'lastUpdatePostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'In all patients cardiac output will be measured using the three methods to evaluate if the values obtained significantly differ'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC).\n\nThe main questions it aims to answer are:\n\n* Are these methods interchangeable?\n* Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consecutive patients aged ≥18 years, referred for RHC for suspected PH, were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Suspected pulmonary hypertension at clinical and echocardiographic evaluation\n\nExclusion Criteria:\n\n* contraindication to Right Heart Catheterization (RHC)\n* cardiac shunt\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05665218', 'briefTitle': 'Comparison of Different Cardiac Output Measurement Methods in Patients Undergoing Right Heart Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'UOSD Emodinamica Diagnostica e Interventistica'}, 'officialTitle': 'Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization', 'orgStudyIdInfo': {'id': 'CH2022-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients undergoing right heart catheterization', 'interventionNames': ['Diagnostic Test: right heart catheterization']}], 'interventions': [{'name': 'right heart catheterization', 'type': 'DIAGNOSTIC_TEST', 'description': 'Right heart catheterization (RHC) is an invasive hemodynamic procedure that allows direct measurement of right-sided cardiac pressures, calculation of cardiac output and pulmonary vascular resistance. It is the gold standard for the diagnosis of pulmonary arterial hypertension. Right heart catheterization is commonly performed by accessing the internal jugular vein (echo-guided access). Swan Ganz catheter with a dedicated thermistor is used to perform RHC; it is advanced through the right heart chambers to measure right atrial, right ventricle, pulmonary artery and pulmonary arterial wedge pressures. Cardiac output is measured using Fick direct, Fick indirect and thermodilution methods.', 'armGroupLabels': ['patients undergoing right heart catheterization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66100', 'city': 'Chieti', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Livio Giuliani, MD PhD', 'role': 'CONTACT', 'email': 'lvgiuliani@gmail.com', 'phone': '3473690091'}, {'name': 'Serena Rossi, MD', 'role': 'CONTACT', 'email': 'rossisere.rs@gmail.com', 'phone': '3286721396'}], 'facility': 'UOSD Emodinamica Diagnostica e Interventistica Ospedale SS Annunziata', 'geoPoint': {'lat': 42.34827, 'lon': 14.16494}}], 'centralContacts': [{'name': 'Livio Giuliani, MD, PhD', 'role': 'CONTACT', 'email': 'lvgiuliani@gmail.com', 'phone': '+390871358978'}, {'name': 'Serena Rossi, MD', 'role': 'CONTACT', 'email': 'rossisere.rs@gmail.com', 'phone': '+390871358978'}], 'overallOfficials': [{'name': 'Livio Giuliani, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Interventional Cardiology Unit, SS Annunziata Hospital, Chieti'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UOSD Emodinamica Diagnostica e Interventistica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Livio Giuliani MD, PhD', 'investigatorFullName': 'Livio Giuliani', 'investigatorAffiliation': 'UOSD Emodinamica Diagnostica e Interventistica'}}}}