Clinical trial NCT04268160: GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
Official title: Glutathione Peroxidase Activity in Subjects With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Glutathione Peroxidase Activity
Aortic Stenosis
Transcatheter Aortic Valve Replacement
Keywords: glutathione peroxidase, GPx, aortic stenosis, transcatheter aortic valve replacement, TAVR
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* 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:

* Previous aortic valve replacement (surgical or TAVR)
* Participants undergoing chemotherapy
* End stage liver disease/cirrhosis (liver produces GSH)

Primary outcomes:
measure: Level of GPx in blood samples
timeFrame: Baseline up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Chinelo Udemgba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redfors, B. A. (2017). Biomarkers in Aortic Stenosis: A systematic Review. Structural Heart. The Journal of the Heart Team, 1-13.
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.
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.
citation: Nimse, S. B. (2015). Free radicals, natural antioxidants, and their reaction mechanism. Royal Society of Chemistry, 27986-28006.
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.
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.
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.
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.
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/