GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR

Aortic Stenosis Clinical Trial

Official title:

Glutathione Peroxidase Activity in Subjects With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04268160
• Other study ID #: IRB201902486
• Status: Withdrawn
• Start date: November 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Glutathione Peroxidase Activity
• Transcatheter Aortic Valve Replacement

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (9)

Arsenault BJ, Boekholdt SM, Dubé MP, Rhéaume 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. — View 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. — View Citation

Bolzán 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. — View Citation

Mahmaljy H, Tawney A, Young M. Transcatheter Aortic Valve Replacement (TAVR/TAVI, Percutaneous Replacement) [Updated 2019 Dec 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-.

Memet C, Gerede DM, Ozenci M, Akbulut IM, Acibuca A, Kiliçkap M, Erol C. Evaluation of the Role of Oxidative Stress in Degenerative Aortic Stenosis. J Heart Valve Dis. 2015 Jul;24(4):445-50. — View Citation

Nimse, S. B. (2015). Free radicals, natural antioxidants, and their reaction mechanism. Royal Society of Chemistry, 27986-28006.

Otto CM. Aortic stenosis and hyperlipidemia: establishing a cause-effect relationship. Am Heart J. 2004 May;147(5):761-3. — View Citation

Redfors, B. A. (2017). Biomarkers in Aortic Stenosis: A systematic Review. Structural Heart. The Journal of the Heart Team, 1-13.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of GPx in blood samples	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	Baseline up to 6 months