GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR

Withdrawn

• Conditions: Glutathione Peroxidase Activity; Aortic Stenosis; Transcatheter Aortic Valve Replacement
• Interventions: 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

• Registration Number: NCT04268160
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Study Start: 2020-11
• Status Verified: 2021-06
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients without aortic stenosis	Blood draw to measure Lp(a) levels	GPx activity levels will be measured on day of recruitment
Patients with severe aortic stenosis undergoing TAVR	Blood draw to measure Lp(a) levels	GPx activity levels will be measured on the day of TAVR procedure, the day of discharge, 1 month, and 6 months after the procedure
Patients without aortic stenosis	Blood draw to measure GPx activity	GPx activity levels will be measured on day of recruitment
Patients with severe aortic stenosis undergoing TAVR	Blood draw to measure SOD activity	GPx activity levels will be measured on the day of TAVR procedure, the day of discharge, 1 month, and 6 months after the procedure
Patients with severe aortic stenosis undergoing TAVR	Blood draw to measure GPx activity	GPx activity levels will be measured on the day of TAVR procedure, the day of discharge, 1 month, and 6 months after the procedure
Patients without aortic stenosis	Blood draw to measure SOD activity	GPx activity levels will be measured on day of recruitment

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Jacksonville, Florida, United States