NCT04268160

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

February 5, 2020

Last Update Submit

June 28, 2021

Conditions

Glutathione Peroxidase ActivityAortic StenosisTranscatheter Aortic Valve Replacement

Keywords

glutathione peroxidase, GPx, aortic stenosis, transcatheter aortic valve replacement, TAVR

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Diagnostic Test: Blood draw to measure GPx activityDiagnostic Test: Blood draw to measure SOD activityDiagnostic Test: Blood draw to measure Lp(a) levels

Patients without aortic stenosis

GPx activity levels will be measured on day of recruitment

Diagnostic Test: Blood draw to measure GPx activityDiagnostic Test: Blood draw to measure SOD activityDiagnostic Test: Blood draw to measure Lp(a) levels

Interventions

Blood draw to measure GPx activityDIAGNOSTIC_TEST

Routine blood draw to measure levels of blood markers.

Patients with severe aortic stenosis undergoing TAVRPatients without aortic stenosis
Blood draw to measure SOD activityDIAGNOSTIC_TEST

Routine blood draw to measure levels of blood markers.

Patients with severe aortic stenosis undergoing TAVRPatients without aortic stenosis
Blood draw to measure Lp(a) levelsDIAGNOSTIC_TEST

Routine blood draw to measure levels of blood markers.

Patients with severe aortic stenosis undergoing TAVRPatients without aortic stenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (9)

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

    BACKGROUND

  • 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: 15131528BACKGROUND

  • 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.

    PMID: 26897814BACKGROUND

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

    BACKGROUND

  • 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: 14573732BACKGROUND

  • 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: 9316738BACKGROUND

  • 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: 31047003BACKGROUND

  • 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: 24704946BACKGROUND

  • 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/

    PMID: 28613729BACKGROUND

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Study Officials

  • Chinelo Udemgba, MD

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 13, 2020

Study Start

November 1, 2020

Primary Completion

June 15, 2021

Study Completion

June 15, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)