Glutathione Peroxidase ActivityNCT04268160
GPx Activity in Subjects With Aortic Stenosis Undergoing TAVR
An observational study of Glutathione Peroxidase Activity and Aortic Stenosis, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glutathione Peroxidase Activity, Aortic Stenosis, Transcatheter Aortic Valve Replacement
- What is being tested?
- Blood draw to measure GPx activity, Blood draw to measure SOD activity and Blood draw to measure Lp(a) levels
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2020to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Previous aortic valve replacement (surgical or TAVR)
- Participants undergoing chemotherapy
- End stage liver disease/cirrhosis (liver produces GSH)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Blood draw to measure GPx activity, Blood draw to measure SOD activity, Blood draw to measure Lp(a) levels
- Keywords
- glutathione peroxidase, GPx, aortic stenosis, transcatheter aortic valve replacement, TAVR
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw to measure GPx activityDiagnostic test
Routine blood draw to measure levels of blood markers.
Blood draw to measure SOD activityDiagnostic test
Routine blood draw to measure levels of blood markers.
Blood draw to measure Lp(a) levelsDiagnostic test
Routine blood draw to measure levels of blood markers.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 | |
| Patients without aortic stenosis | GPx activity levels will be measured on day of recruitment Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study startNov 2020 (estimated)
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: Funding issues and closed with the IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Glutathione Peroxidase ActivityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chinelo Udemgba, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268160
- Sponsor's protocol ID
- IRB201902486
- Status last verified
- Jun 2021
- First submitted
- 5 Feb 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Redfors, B. A. (2017). Biomarkers in Aortic Stenosis: A systematic Review. Structural Heart. The Journal of the Heart Team, 1-13.
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.
PubMed 15131528Memet 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.
PubMed 26897814Nimse, S. B. (2015). Free radicals, natural antioxidants, and their reaction mechanism. Royal Society of Chemistry, 27986-28006.
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.
PubMed 14573732Bolzan 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.
PubMed 9316738Zheng 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.
PubMed 31047003Arsenault 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.
PubMed 24704946Mahmaljy 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-.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutathione Peroxidase Activity in Subjects With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.
- ClinicalTrials.gov ID
- NCT04268160
- Acronym / sponsor ID
- IRB201902486
- Keywords
- glutathione peroxidase, GPx, aortic stenosis, transcatheter aortic valve replacement, TAVR
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues and closed with the IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with severe aortic stenosis undergoing TAVR | – | Diagnostic Test: Blood draw to measure GPx activity, Diagnostic Test: Blood draw to measure SOD activity, Diagnostic Test: Blood draw to measure Lp(a) levelsGPx 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 | – | Diagnostic Test: Blood draw to measure GPx activity, Diagnostic Test: Blood draw to measure SOD activity, Diagnostic Test: Blood draw to measure Lp(a) levelsGPx activity levels will be measured on day of recruitment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Previous aortic valve replacement (surgical or TAVR)
- Participants undergoing chemotherapy
- End stage liver disease/cirrhosis (liver produces GSH)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draw to measure GPx activityRoutine blood draw to measure levels of blood markers. | Diagnostic test | Patients with severe aortic stenosis undergoing TAVR, Patients without aortic stenosis |
| Blood draw to measure SOD activityRoutine blood draw to measure levels of blood markers. | Diagnostic test | Patients with severe aortic stenosis undergoing TAVR, Patients without aortic stenosis |
| Blood draw to measure Lp(a) levelsRoutine blood draw to measure levels of blood markers. | Diagnostic test | Patients with severe aortic stenosis undergoing TAVR, Patients without aortic stenosis |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- BackgroundRedfors, B. A. (2017). Biomarkers in Aortic Stenosis: A systematic Review. Structural Heart. The Journal of the Heart Team, 1-13.
- Background: PubMed 15131528Otto 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.
- Background: PubMed 26897814Memet 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.
- BackgroundNimse, S. B. (2015). Free radicals, natural antioxidants, and their reaction mechanism. Royal Society of Chemistry, 27986-28006.
- Background: PubMed 14573732Blankenberg 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.
- Background: PubMed 9316738Bolzan 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.
- Background: PubMed 31047003Zheng 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.
- Background: PubMed 24704946Arsenault 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.
- BackgroundMahmaljy 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-.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chinelo Udemgba, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glutathione Peroxidase Activity and Aortic Stenosis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of GPx in blood samples (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04268160, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.