Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-05 @ 3:00 PM
Study NCT ID:
NCT04268160
Status:
WITHDRAWN
Last Update Posted:
2021-06-30
First Post:
2020-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Funding issues and closed with the IRB', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of GPx in blood samples', 'timeFrame': 'Baseline up to 6 months', 'description': 'Glutathione peroxidase activity levels measured from whole blood in U/L units in participants with severe aortic stenosis after transcatheter valve replacement compared with the matched population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glutathione peroxidase, GPx, aortic stenosis, transcatheter aortic valve replacement, TAVR'], 'conditions': ['Glutathione Peroxidase Activity', 'Aortic Stenosis', 'Transcatheter Aortic Valve Replacement']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Redfors, B. A. (2017). Biomarkers in Aortic Stenosis: A systematic Review. Structural Heart. The Journal of the Heart Team, 1-13.'}, {'pmid': '15131528', 'type': 'BACKGROUND', 'citation': 'Otto CM. Aortic stenosis and hyperlipidemia: establishing a cause-effect relationship. Am Heart J. 2004 May;147(5):761-3. doi: 10.1016/j.ahj.2003.12.014. No abstract available.'}, {'pmid': '26897814', 'type': 'BACKGROUND', 'citation': 'Memet C, Gerede DM, Ozenci M, Akbulut IM, Acibuca A, Kilickap M, Erol C. Evaluation of the Role of Oxidative Stress in Degenerative Aortic Stenosis. J Heart Valve Dis. 2015 Jul;24(4):445-50.'}, {'type': 'BACKGROUND', 'citation': 'Nimse, S. B. (2015). Free radicals, natural antioxidants, and their reaction mechanism. Royal Society of Chemistry, 27986-28006.'}, {'pmid': '14573732', 'type': 'BACKGROUND', 'citation': 'Blankenberg S, Rupprecht HJ, Bickel C, Torzewski M, Hafner G, Tiret L, Smieja M, Cambien F, Meyer J, Lackner KJ; AtheroGene Investigators. Glutathione peroxidase 1 activity and cardiovascular events in patients with coronary artery disease. N Engl J Med. 2003 Oct 23;349(17):1605-13. doi: 10.1056/NEJMoa030535.'}, {'pmid': '9316738', 'type': 'BACKGROUND', 'citation': 'Bolzan AD, Bianchi MS, Bianchi NO. Superoxide dismutase, catalase and glutathione peroxidase activities in human blood: influence of sex, age and cigarette smoking. Clin Biochem. 1997 Aug;30(6):449-54. doi: 10.1016/s0009-9120(97)00047-7.'}, {'pmid': '31047003', 'type': 'BACKGROUND', 'citation': 'Zheng KH, Tsimikas S, Pawade T, Kroon J, Jenkins WSA, Doris MK, White AC, Timmers NKLM, Hjortnaes J, Rogers MA, Aikawa E, Arsenault BJ, Witztum JL, Newby DE, Koschinsky ML, Fayad ZA, Stroes ESG, Boekholdt SM, Dweck MR. Lipoprotein(a) and Oxidized Phospholipids Promote Valve Calcification in Patients With Aortic Stenosis. J Am Coll Cardiol. 2019 May 7;73(17):2150-2162. doi: 10.1016/j.jacc.2019.01.070.'}, {'pmid': '24704946', 'type': 'BACKGROUND', 'citation': 'Arsenault BJ, Boekholdt SM, Dube MP, Rheaume E, Wareham NJ, Khaw KT, Sandhu MS, Tardif JC. Lipoprotein(a) levels, genotype, and incident aortic valve stenosis: a prospective Mendelian randomization study and replication in a case-control cohort. Circ Cardiovasc Genet. 2014 Jun;7(3):304-10. doi: 10.1161/CIRCGENETICS.113.000400. Epub 2014 Apr 5.'}, {'pmid': '28613729', 'type': 'BACKGROUND', 'citation': 'Mahmaljy H, Tawney A, Young M. Transcatheter Aortic Valve Replacement. 2023 Jul 24. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431075/'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure. The burden of oxidative stress will be determined by the measurement of GPx, superoxide dismutase (SOD) and lipoprotein A (Lp(a)). We hypothesize GPx activity is reduced in participants with severe AS vs control groups and GPx activity is to increase after TAVR is performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study participants with severe aortic stenosis undergoing TAVR. They will be matched with patients without aortic stenosis based on age, gender, race, and co-morbidities (including stroke, history of coronary artery disease, heart failure, diabetes, hypertension, and other valvular diseases).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Patients with severe AS including participants with low flow, low gradient severe AS and paradoxical severe AS\n* Patients meeting criteria for TAVR procedure\n\nExclusion Criteria:\n\n* Previous aortic valve replacement (surgical or TAVR)\n* Participants undergoing chemotherapy\n* End stage liver disease/cirrhosis (liver produces GSH)'}, 'identificationModule': {'nctId': 'NCT04268160', 'briefTitle': 'GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Glutathione Peroxidase Activity in Subjects With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.', 'orgStudyIdInfo': {'id': 'IRB201902486'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with severe aortic stenosis undergoing TAVR', 'description': 'GPx activity levels will be measured on the day of TAVR procedure, the day of discharge, 1 month, and 6 months after the procedure', 'interventionNames': ['Diagnostic Test: Blood draw to measure GPx activity', 'Diagnostic Test: Blood draw to measure SOD activity', 'Diagnostic Test: Blood draw to measure Lp(a) levels']}, {'label': 'Patients without aortic stenosis', 'description': 'GPx activity levels will be measured on day of recruitment', 'interventionNames': ['Diagnostic Test: Blood draw to measure GPx activity', 'Diagnostic Test: Blood draw to measure SOD activity', 'Diagnostic Test: Blood draw to measure Lp(a) levels']}], 'interventions': [{'name': 'Blood draw to measure GPx activity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine blood draw to measure levels of blood markers.', 'armGroupLabels': ['Patients with severe aortic stenosis undergoing TAVR', 'Patients without aortic stenosis']}, {'name': 'Blood draw to measure SOD activity', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine blood draw to measure levels of blood markers.', 'armGroupLabels': ['Patients with severe aortic stenosis undergoing TAVR', 'Patients without aortic stenosis']}, {'name': 'Blood draw to measure Lp(a) levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Routine blood draw to measure levels of blood markers.', 'armGroupLabels': ['Patients with severe aortic stenosis undergoing TAVR', 'Patients without aortic stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Chinelo Udemgba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}