GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR

June 28, 2021 updated by: University of Florida

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of GPx in blood samples
Time Frame: 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
Baseline up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ACTUAL)

June 15, 2021

Study Completion (ACTUAL)

June 15, 2021

Study Registration Dates

First Submitted

February 5, 2020

First Submitted That Met QC Criteria

February 11, 2020

First Posted (ACTUAL)

February 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201902486

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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