Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT03404258
Status:
RECRUITING
Last Update Posted:
2024-12-11
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080039', 'term': 'Univentricular Heart'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-06', 'studyFirstSubmitDate': '2018-01-11', 'studyFirstSubmitQcDate': '2018-01-11', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in ET1 concentration between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.', 'timeFrame': '48 hours post-operatively'}, {'measure': 'Difference in metabolomics profile between controls, study patients at pre-SCPA catheterization, and study patients in the post-operative period.', 'timeFrame': '48 hours post-operatively'}], 'secondaryOutcomes': [{'measure': 'Association between ET1 concentration at pre-SCPA catheterization in study patients and clinical metrics of pre-operative pulmonary adequacy.', 'timeFrame': '48 hours post-operatively'}, {'measure': 'Association between metabolomics profile in study patients and clinical metrics of pre-operative pulmonary adequacy.', 'timeFrame': '48 hours post-operatively'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Single-ventricle', 'Pulmonary Vascular Resistance Abnormality', 'Superior Cavo-Pulmonary Anastomosis', 'Endothelin', 'Metabolomics']}, 'referencesModule': {'references': [{'pmid': '33045409', 'type': 'DERIVED', 'citation': 'Frank BS, Khailova L, Silveira L, Mitchell MB, Morgan GJ, Hsieh EWY, DiMaria MV, Twite M, Klawitter J, Davidson JA. Proteomic profiling identifies key differences between inter-stage infants with single ventricle heart disease and healthy controls. Transl Res. 2021 Mar;229:24-37. doi: 10.1016/j.trsl.2020.10.001. Epub 2020 Oct 9.'}]}, 'descriptionModule': {'briefSummary': 'This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased post-operative pulmonary blood flow in single ventricle patients undergoing superior cavo-pulmonary anastomosis (SCPA). The study will utilize a combined targeted and untargeted approach to both optimize translation of a promising existing biomarker and efficiently identify novel biomarkers and potential therapeutic targets in this population.', 'detailedDescription': 'Overall Hypothesis: Endothelin-1 (ET1) and associated dysregulation of key metabolic pathways decrease pre-operative pulmonary blood vessel development and increase post-operative pulmonary blood vessel resistance leading to decreased pulmonary blood flow in patients undergoing SCPA.\n\nFor enrolled patients, collected data will include:\n\n* 3 mL blood sample (x2) at pre-SCPA catheterization.\n* 3 mL blood samples at 2, 24, and 48 hours post-operative.\n* Urine sample pre-operatively and post-operatively\n* Collection of otherwise-discarded operative tissue sample from the pulmonary artery.\n* Collection of clinical data, demographic data, and results of routine, post-operative hemodynamic monitoring.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants with single ventricle heart disease undergoing trans-catheter evaluation in anticipation of superior cavo-pulmonary anastomosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Congenital heart disease patients undergoing catheterization for pre-SPCA evaluation or undergoing SCPA without plans for cardiac catheterization (utilizing data from a previously performed clinical catheterization).\n* All patients will have age from 31 days to 2 years.\n\nExclusion Criteria:\n\n* Patients who will remain post-op with a pulsatile source of pulmonary blood flow in addition to the cavo-pulmonary anastomosis (so called "1.5 ventricle" repair) will be excluded.\n* Due to limitations in acceptable sample blood volumes for research, patients with weight \\<4kg will be excluded.\n* Patients will not be excluded on the basis of gender, ethnicity, genetic diagnosis, gestational age at birth, non-cardiac comorbidity, or pre-operative medication regimen.'}, 'identificationModule': {'nctId': 'NCT03404258', 'briefTitle': 'ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis', 'orgStudyIdInfo': {'id': '17-0832'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study Patients', 'description': 'Infants between 1 month and 2 years of age undergoing evaluation for SCPA candidacy.', 'interventionNames': ['Other: Research Blood Sampling']}, {'label': 'Control Patients', 'description': 'Infants between 3 months and 12 months of age with no known cardio-pulmonary disease, no active infection, and no known genetic abnormality undergoing elective surgery for a non-cardiac indication.', 'interventionNames': ['Other: Research Blood Sampling']}], 'interventions': [{'name': 'Research Blood Sampling', 'type': 'OTHER', 'description': 'Blood samples will be collected at specified time points and research assays will be performed.', 'armGroupLabels': ['Control Patients', 'Study Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin S Frank, MD', 'role': 'CONTACT', 'email': 'Benjamin.Frank@childrenscolorado.org', 'phone': '720-777-6820'}, {'name': 'Jesse A Davidson, MD', 'role': 'CONTACT', 'email': 'Jesse.Davidson@childrenscolorado.org', 'phone': '720-777-6820'}, {'name': 'Benjamin S Frank, MD', 'role': 'CONTACT'}], 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'centralContacts': [{'name': 'Benjamin Frank, MD', 'role': 'CONTACT', 'email': 'Benjamin.Frank@childrenscolorado.org', 'phone': '720 777 1954'}, {'name': 'Jesse Davidson, MD', 'role': 'CONTACT', 'email': 'Jesse.Davidson@childrenscolorado.org'}], 'overallOfficials': [{'name': 'Benjamin Frank, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}