GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
NCT ID: NCT04268160
Last Updated: 2021-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-11-30
2021-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with severe aortic stenosis undergoing TAVR
GPx activity levels will be measured on the day of TAVR procedure, the day of discharge, 1 month, and 6 months after the procedure
Blood draw to measure GPx activity
Routine blood draw to measure levels of blood markers.
Blood draw to measure SOD activity
Routine blood draw to measure levels of blood markers.
Blood draw to measure Lp(a) levels
Routine blood draw to measure levels of blood markers.
Patients without aortic stenosis
GPx activity levels will be measured on day of recruitment
Blood draw to measure GPx activity
Routine blood draw to measure levels of blood markers.
Blood draw to measure SOD activity
Routine blood draw to measure levels of blood markers.
Blood draw to measure Lp(a) levels
Routine blood draw to measure levels of blood markers.
Interventions
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Blood draw to measure GPx activity
Routine blood draw to measure levels of blood markers.
Blood draw to measure SOD activity
Routine blood draw to measure levels of blood markers.
Blood draw to measure Lp(a) levels
Routine blood draw to measure levels of blood markers.
Eligibility Criteria
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Inclusion Criteria
* Patients with severe AS including participants with low flow, low gradient severe AS and paradoxical severe AS
* Patients meeting criteria for TAVR procedure
Exclusion Criteria
* Participants undergoing chemotherapy
* End stage liver disease/cirrhosis (liver produces GSH)
18 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Chinelo Udemgba, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Jacksonville, Florida, United States
Countries
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References
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Redfors, B. A. (2017). Biomarkers in Aortic Stenosis: A systematic Review. Structural Heart. The Journal of the Heart Team, 1-13.
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.
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.
Nimse, S. B. (2015). Free radicals, natural antioxidants, and their reaction mechanism. Royal Society of Chemistry, 27986-28006.
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.
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.
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.
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.
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/
Other Identifiers
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IRB201902486
Identifier Type: -
Identifier Source: org_study_id
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