Aortic StenosisROSNCT02841917
Reactive Oxygen Species Following Aortic Valve Replacement
An observational study of Aortic Stenosis, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with severe AS are deemed inoperable due to comorbidities such as severe respiratory disease, chronic renal disease and peripheral vascular… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aortic Stenosis
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Nov 2016to 31 Mar 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe symptomatic aortic stenosis undergoing transcatheter or surgical aortic valve replacement.
Who may be able to join
- 1. Severe symptomatic aortic stenosis defined as aortic valve area <1 cm2, mean aortic gradient >40 mm Hg or Vmax > 4 m/s amenable for transcatheter or surgical aortic valve replacement.
Who cannot join
- Severe comorbidities , advance age, frailty or thoracic anatomy unfavorable for surgical aortic valve replacement.
- Anatomy precluding transcatheter aortic valve replacement.
- Requirement for concomitant coronary artery bypass grafting.
- Requirement for concomitant mitral, tricuspid, or pulmonary valve surgery.
- Allergy to aspirin or clopidogrel.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: Oxidative Stress Response in Patients With Severe Aortic Stenosis Undergoing Transcatheter or Surgical Aortic Valve Replacement (ROS Study)
Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with severe AS are deemed inoperable due to comorbidities such as severe respiratory disease, chronic renal disease and peripheral vascular disease. Transcatheter aortic valve replacement (TAVR) has emerged as a novel therapeutic modality for inoperable patients and an effective alternative to SAVR in selected high and intermediate-risk patients. Myocardial ischemia and reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter time of ischemia and hypotension and may be associated with less ROS mediated MRI. Inflammatory responses and reperfusion injury following TAVR have not been previously described nor compared to SAVR. The aim of this study is therefore to compare the oxidative stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and determine whether it correlates with clinical outcomes.
Read the detailed description
Myocardial ischemia and reperfusion injury (MRI) related to cardio-pulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. Changes in ROS following SAVR have been well documented in the literature. Furthermore, pre-operative ROS markers such as malondialdehyde have been shown to be predictors of adverse outcomes after 30-day and 1-year follow-up. In contrast to SAVR, TAVR is associated with shorter duration of myocardial ischemia and hypotension ad may thus be associated with a lower degree of MRI. Inflammatory responses and reperfusion injury following TAVR have not been described nor have they been compared with SAVR.
Cellular respiration leads to the generation of partially reduced oxygen derivatives called ROS. Under normal physiological conditions, ROS serve as integral components of cellular signaling pathways. A balanced redox state is established between the major ROS producing systems (NADPH oxidase, xanthine oxidase, nitric oxide synthase, myeloperoxidase and lipoxygenases) and the major antioxidant systems (catalase, α-tocopherol, ascorbic acid, superoxide dismutase, glutathione peroxidase and glutathione S transferases that conjugate reduced GSH to hydrophobic organic compounds and glutathione). Excess production or reduced degradation of ROS by the antioxidant defense systems imposes an oxidative burden upon the cellular environment leading to modification of numerous biomolecules and functional defects.
In MRI the enzyme xanthine oxidase catalyzes the formation of uric acid with the coproduction of superoxide. Superoxide release results in the recruitment and activation of neutrophils and their adherence to endothelial cells, which stimulates the formation of xanthine oxidase in the endothelium, with further superoxide production. Oxidation of DNA and proteins may then follow leading to membrane damage because of lipid peroxidation leading to alterations in membrane permeability, modification of protein structure and functional changes. Oxidative damage to the mitochondrial membrane can also occur resulting in membrane depolarization and the uncoupling of oxidative phosphorylation with altered cellular respiration. This can ultimately lead to mitochondrial damage, release of cytochrome c, activation of caspases and apoptosis.
Although TAVR may not expose the myocardium to the same level of MRI than SAVR, patients undergoing TAVR have greater numbers of co-morbidities and may thus have a greater baseline ROS burden than patients undergoing SAVR. As the generation of ROS in patients undergoing TAVR and whether differences in ROS levels in such patients correlates with clinical outcomes has not been described. The prospective study will attempt to address both of these questions.
- Conditions
- Aortic Stenosis
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement | ROS Post TAVR | |
| Surgical Aortic Valve Replacement | ROS Post SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ascertain the concentrations of serum isoprostanes, nitrites and sulphides following transcatheter and surgical aortic valve replacement.
Serum measurements will be undertaken using standard immunoassay techniques.
Measured: 24 hours
Secondary outcomes (4)
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with cardiovascular mortality.
Clinical follow-up will be undertaken either by a clinic visit or by telephone contact.
Measured: 30 days clinical follow-up
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with myocardial infarction.
Clinical follow-up will be undertaken either by a clinic visit or by telephone contact.
Measured: 30 days clinical follow-up.
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with stroke.
Clinical follow-up will be undertaken either by a clinic visit or by telephone contact.
Measured: 30 days clinical follow-up.
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with major bleeding.
Clinical follow-up will be undertaken either by a clinic visit or by telephone contact.
Measured: 30 days clinical follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start29 Nov 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Mahmoudi, MD,PhD, Principal investigator, University Hospital Southampton NHS Foundation TrustGabriel Maluenda, MD, Study director, Centro Cardiovascular, Hospital San Borja, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841917
- Sponsor's protocol ID
- RHM CAR0508
- Acronym
- ROS
- Status last verified
- Sep 2018
- First submitted
- 13 Jul 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.
PubMed 24939033Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD Jr, Gualano SK. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):533-9. doi: 10.1161/CIRCOUTCOMES.109.848259. Epub 2009 Oct 27.
PubMed 20031890Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
PubMed 21639811Larmann J, Theilmeier G. Inflammatory response to cardiac surgery: cardiopulmonary bypass versus non-cardiopulmonary bypass surgery. Best Pract Res Clin Anaesthesiol. 2004 Sep;18(3):425-38. doi: 10.1016/j.bpa.2003.12.004.
PubMed 15212337Scolletta S, Carlucci F, Biagioli B, Marchetti L, Maccherini M, Carlucci G, Rosi F, Salvi M, Tabucchi A. NT-proBNP changes, oxidative stress, and energy status of hypertrophic myocardium following ischemia/reperfusion injury. Biomed Pharmacother. 2007 Feb-Apr;61(2-3):160-6. doi: 10.1016/j.biopha.2006.10.007. Epub 2007 Feb 20.
PubMed 17350221Cavalca V, Tremoli E, Porro B, Veglia F, Myasoedova V, Squellerio I, Manzone D, Zanobini M, Trezzi M, Di Minno MN, Werba JP, Tedesco C, Alamanni F, Parolari A. Oxidative stress and nitric oxide pathway in adult patients who are candidates for cardiac surgery: patterns and differences. Interact Cardiovasc Thorac Surg. 2013 Dec;17(6):923-30. doi: 10.1093/icvts/ivt386. Epub 2013 Sep 7.
PubMed 24014619Hausenloy DJ, Yellon DM. The evolving story of "conditioning" to protect against acute myocardial ischaemia-reperfusion injury. Heart. 2007 Jun;93(6):649-51. doi: 10.1136/hrt.2007.118828.
PubMed 17502643Rodrigo R, Korantzopoulos P, Cereceda M, Asenjo R, Zamorano J, Villalabeitia E, Baeza C, Aguayo R, Castillo R, Carrasco R, Gormaz JG. A randomized controlled trial to prevent post-operative atrial fibrillation by antioxidant reinforcement. J Am Coll Cardiol. 2013 Oct 15;62(16):1457-65. doi: 10.1016/j.jacc.2013.07.014. Epub 2013 Jul 31.
PubMed 23916928Granger DN. Role of xanthine oxidase and granulocytes in ischemia-reperfusion injury. Am J Physiol. 1988 Dec;255(6 Pt 2):H1269-75. doi: 10.1152/ajpheart.1988.255.6.H1269.
PubMed 3059826Zimmerman JJ. Defining the role of oxyradicals in the pathogenesis of sepsis. Crit Care Med. 1995 Apr;23(4):616-7. doi: 10.1097/00003246-199504000-00003. No abstract available.
PubMed 7712748Macdonald J, Galley HF, Webster NR. Oxidative stress and gene expression in sepsis. Br J Anaesth. 2003 Feb;90(2):221-32. doi: 10.1093/bja/aeg034.
PubMed 12538380
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Stress Response in Patients With Severe Aortic Stenosis Undergoing Transcatheter or Surgical Aortic Valve Replacement (ROS Study)
- ClinicalTrials.gov ID
- NCT02841917
- Acronym / sponsor ID
- ROS / RHM CAR0508
- Conditions
- Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 22 Jul 2016 (estimated)
- 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.
Surgical aortic valve replacement (SVAR) is currently the 'Gold Standard' therapy for patients with severe symptomatic aortic stenosis (AS). Approximately 30-50% of patients with severe AS are deemed inoperable due to comorbidities such as severe respiratory disease, chronic renal disease and peripheral vascular disease. Transcatheter aortic valve replacement (TAVR) has emerged as a novel therapeutic modality for inoperable patients and an effective alternative to SAVR in selected high and intermediate-risk patients. Myocardial ischemia and reperfusion injury (MRI), mediated by reactive oxygen species (ROS), related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. In contrast to SAVR, transcatheter deployment of aortic prostheses requires shorter time of ischemia and hypotension and may be associated with less ROS mediated MRI. Inflammatory responses and reperfusion injury following TAVR have not been previously described nor compared to SAVR. The aim of this study is therefore to compare the oxidative stress response in patients with isolated severe symptomatic AS undergoing SAVR or TAVR and determine whether it correlates with clinical outcomes.
Detailed description
Myocardial ischemia and reperfusion injury (MRI) related to cardio-pulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. Changes in ROS following SAVR have been well documented in the literature. Furthermore, pre-operative ROS markers such as malondialdehyde have been shown to be predictors of adverse outcomes after 30-day and 1-year follow-up. In contrast to SAVR, TAVR is associated with shorter duration of myocardial ischemia and hypotension ad may thus be associated with a lower degree of MRI. Inflammatory responses and reperfusion injury following TAVR have not been described nor have they been compared with SAVR.
Cellular respiration leads to the generation of partially reduced oxygen derivatives called ROS. Under normal physiological conditions, ROS serve as integral components of cellular signaling pathways. A balanced redox state is established between the major ROS producing systems (NADPH oxidase, xanthine oxidase, nitric oxide synthase, myeloperoxidase and lipoxygenases) and the major antioxidant systems (catalase, α-tocopherol, ascorbic acid, superoxide dismutase, glutathione peroxidase and glutathione S transferases that conjugate reduced GSH to hydrophobic organic compounds and glutathione). Excess production or reduced degradation of ROS by the antioxidant defense systems imposes an oxidative burden upon the cellular environment leading to modification of numerous biomolecules and functional defects.
In MRI the enzyme xanthine oxidase catalyzes the formation of uric acid with the coproduction of superoxide. Superoxide release results in the recruitment and activation of neutrophils and their adherence to endothelial cells, which stimulates the formation of xanthine oxidase in the endothelium, with further superoxide production. Oxidation of DNA and proteins may then follow leading to membrane damage because of lipid peroxidation leading to alterations in membrane permeability, modification of protein structure and functional changes. Oxidative damage to the mitochondrial membrane can also occur resulting in membrane depolarization and the uncoupling of oxidative phosphorylation with altered cellular respiration. This can ultimately lead to mitochondrial damage, release of cytochrome c, activation of caspases and apoptosis.
Although TAVR may not expose the myocardium to the same level of MRI than SAVR, patients undergoing TAVR have greater numbers of co-morbidities and may thus have a greater baseline ROS burden than patients undergoing SAVR. As the generation of ROS in patients undergoing TAVR and whether differences in ROS levels in such patients correlates with clinical outcomes has not been described. The prospective study will attempt to address both of these questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement | – | –ROS Post TAVR |
| Surgical Aortic Valve Replacement | – | –ROS Post SAVR |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe symptomatic aortic stenosis undergoing transcatheter or surgical aortic valve replacement.
Key inclusion criteria (1 listed)
- 1. Severe symptomatic aortic stenosis defined as aortic valve area <1 cm2, mean aortic gradient >40 mm Hg or Vmax > 4 m/s amenable for transcatheter or surgical aortic valve replacement.
Key exclusion criteria (5 listed)
- Severe comorbidities , advance age, frailty or thoracic anatomy unfavorable for surgical aortic valve replacement.
- Anatomy precluding transcatheter aortic valve replacement.
- Requirement for concomitant coronary artery bypass grafting.
- Requirement for concomitant mitral, tricuspid, or pulmonary valve surgery.
- Allergy to aspirin or clopidogrel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ascertain the concentrations of serum isoprostanes, nitrites and sulphides following transcatheter and surgical aortic valve replacement.
Time frame: 24 hours
Serum measurements will be undertaken using standard immunoassay techniques.
4 secondary outcomes
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with cardiovascular mortality.
Time frame: 30 days clinical follow-up
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with myocardial infarction.
Time frame: 30 days clinical follow-up.
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with stroke.
Time frame: 30 days clinical follow-up.
Ascertain potential differences in the generation of reactive oxygen species that have been outlined in the primary outcomes with major bleeding.
Time frame: 30 days clinical follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Results publication: PubMed 24939033Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.
- Results publication: PubMed 20031890Bach DS, Siao D, Girard SE, Duvernoy C, McCallister BD Jr, Gualano SK. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk. Circ Cardiovasc Qual Outcomes. 2009 Nov;2(6):533-9. doi: 10.1161/CIRCOUTCOMES.109.848259. Epub 2009 Oct 27.
- Results publication: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Results publication: PubMed 21639811Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- Results publication: PubMed 15212337Larmann J, Theilmeier G. Inflammatory response to cardiac surgery: cardiopulmonary bypass versus non-cardiopulmonary bypass surgery. Best Pract Res Clin Anaesthesiol. 2004 Sep;18(3):425-38. doi: 10.1016/j.bpa.2003.12.004.
- Results publication: PubMed 17350221Scolletta S, Carlucci F, Biagioli B, Marchetti L, Maccherini M, Carlucci G, Rosi F, Salvi M, Tabucchi A. NT-proBNP changes, oxidative stress, and energy status of hypertrophic myocardium following ischemia/reperfusion injury. Biomed Pharmacother. 2007 Feb-Apr;61(2-3):160-6. doi: 10.1016/j.biopha.2006.10.007. Epub 2007 Feb 20.
- Results publication: PubMed 24014619Cavalca V, Tremoli E, Porro B, Veglia F, Myasoedova V, Squellerio I, Manzone D, Zanobini M, Trezzi M, Di Minno MN, Werba JP, Tedesco C, Alamanni F, Parolari A. Oxidative stress and nitric oxide pathway in adult patients who are candidates for cardiac surgery: patterns and differences. Interact Cardiovasc Thorac Surg. 2013 Dec;17(6):923-30. doi: 10.1093/icvts/ivt386. Epub 2013 Sep 7.
- Results publication: PubMed 17502643Hausenloy DJ, Yellon DM. The evolving story of "conditioning" to protect against acute myocardial ischaemia-reperfusion injury. Heart. 2007 Jun;93(6):649-51. doi: 10.1136/hrt.2007.118828.
- Results publication: PubMed 23916928Rodrigo R, Korantzopoulos P, Cereceda M, Asenjo R, Zamorano J, Villalabeitia E, Baeza C, Aguayo R, Castillo R, Carrasco R, Gormaz JG. A randomized controlled trial to prevent post-operative atrial fibrillation by antioxidant reinforcement. J Am Coll Cardiol. 2013 Oct 15;62(16):1457-65. doi: 10.1016/j.jacc.2013.07.014. Epub 2013 Jul 31.
- Results publication: PubMed 3059826Granger DN. Role of xanthine oxidase and granulocytes in ischemia-reperfusion injury. Am J Physiol. 1988 Dec;255(6 Pt 2):H1269-75. doi: 10.1152/ajpheart.1988.255.6.H1269.
- Results publication: PubMed 7712748Zimmerman JJ. Defining the role of oxyradicals in the pathogenesis of sepsis. Crit Care Med. 1995 Apr;23(4):616-7. doi: 10.1097/00003246-199504000-00003. No abstract available.
- Results publication: PubMed 12538380Macdonald J, Galley HF, Webster NR. Oxidative stress and gene expression in sepsis. Br J Anaesth. 2003 Feb;90(2):221-32. doi: 10.1093/bja/aeg034.
- Individual participant dataSharing planned: No
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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.
Michael Mahmoudi, MD,PhD principal investigator
University Hospital Southampton NHS Foundation Trust
Gabriel Maluenda, MD study director
Centro Cardiovascular, Hospital San Borja, Chile
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 Aortic Stenosis, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 6 Sep 2018. 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 Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ascertain the concentrations of serum isoprostanes, nitrites and sulphides following transcatheter and surgical aortic valve replacement. (time frame: 24 hours). 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 NCT02841917, which also lists 12 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 6 Sep 2018; AzTrials last refreshed its copy on 2 Nov 2026.