GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR

Sponsor
University of Florida (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04268160
Collaborator
(none)
0
1
7.4
0

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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

Study Design

Study Type:
Observational
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Glutathione Peroxidase Activity in Subjects With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.
Anticipated Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
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 activity
Routine blood draw to measure levels of blood markers.

Diagnostic Test: Blood draw to measure SOD activity
Routine blood draw to measure levels of blood markers.

Diagnostic Test: 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

Diagnostic Test: Blood draw to measure GPx activity
Routine blood draw to measure levels of blood markers.

Diagnostic Test: Blood draw to measure SOD activity
Routine blood draw to measure levels of blood markers.

Diagnostic Test: Blood draw to measure Lp(a) levels
Routine blood draw to measure levels of blood markers.

Outcome Measures

Primary Outcome Measures

  1. Level of GPx in blood samples [Baseline up to 6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Florida Jacksonville Florida United States 32209

Sponsors and Collaborators

  • University of Florida

Investigators

  • Principal Investigator: Chinelo Udemgba, MD, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT04268160
Other Study ID Numbers:
  • IRB201902486
First Posted:
Feb 13, 2020
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2021