HealthyNCT00824759
Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing
A study testing pure oxygen breathing versus air in people with Healthy and Coronary Artery Bypass Graft, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations. Besides its main function in erythropoiesis, EPO has also shown tissue protective effects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Coronary Artery Bypass Graft
- What is being tested?
- pure oxygen breathing versus air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy non-smokers; patients undergoing CABG under cardiopulmonary bypass
Who cannot join
- Subjects with a pulmonary disease; subjects who have stayed at high altitude since at least 3 months; healthy subjects taking medication; patients undergoing a redo or combined cardiac surgery; patients with renal insufficiency; any emergency CABG; Patients with pulmonary disease
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
About this study
Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations.
Besides its main function in erythropoiesis, EPO has also shown tissue protective effects. The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.
Read the detailed description
Currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (EPO) production. However, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for EPO production. To confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects.
The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.
The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.
- Conditions
- Healthy, Coronary Artery Bypass Graft
- Being tested
- pure oxygen breathing versus air
- Keywords
- Healthy subjects, CABG, Patients undergoing coronary artery bypass graft under cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pure oxygen breathing versus airOther
one group will breath pure oxygen; the other will breath air
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Other: pure oxygen breathing versus air |
| oxygen | Active comparator | Not described Receives: Other: pure oxygen breathing versus air |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease in Troponin-I values
Measured: 12h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
Why it stopped: Because it seemed not of interest based on the current literature
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Momeni, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824759
- Sponsor's protocol ID
- 2008/24NOV/331
- Status last verified
- Nov 2014
- First submitted
- 16 Jan 2009
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Balestra C, Germonpre P, Poortmans JR, Marroni A. Serum erythropoietin levels in healthy humans after a short period of normobaric and hyperbaric oxygen breathing: the "normobaric oxygen paradox". J Appl Physiol (1985). 2006 Feb;100(2):512-8. doi: 10.1152/japplphysiol.00964.2005. Epub 2005 Oct 20.
PubMed 16239610Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007. doi: 10.1172/JCI18200.
PubMed 14523037
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing
- ClinicalTrials.gov ID
- NCT00824759
- Acronym / sponsor ID
- 2008/24NOV/331
- Conditions
- Healthy, Coronary Artery Bypass Graft
- Keywords
- Healthy subjects, CABG, Patients undergoing coronary artery bypass graft under cardiopulmonary bypass
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because it seemed not of interest based on the current literature
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- First posted
- 19 Jan 2009 (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.
Tissue hypoxia is the only accepted trigger for erythropoietin (EPO) production. However, in healthy subjects EPO concentrations have also increased after oxygen breathing. The aim of our study is to confirm these observations.
Besides its main function in erythropoiesis, EPO has also shown tissue protective effects. The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.
Detailed description
Currently, renal tissue hypoxia is the only widely accepted trigger for erythropoietin (EPO) production. However, previous studies in healthy subjects have demonstrated that a sudden and sustained decrease in tissue oxygen level, aside from an absolute low level of tissue oxygen tension, could also act as a trigger for EPO production. To confirm these observations and to clarify an eventual role of free oxygen radicals and antioxidants, hypobaric pure oxygen will be administered to healthy subjects.
The major physiologic function of EPO is thought to be the induction of erythropoiesis. However, a growing body of evidence indicates that EPO has tissue-protective effects and prevents tissue damage during ischemia. In an ex vivo proof-of-concept, protective effects of EPO have been shown in human myocardium.
The second goal of our study is to observe the cardioprotective effects of increased endogenous EPO, induced after normobaric oxygen breathing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Other: pure oxygen breathing versus air |
| oxygen | Active comparator | Other: pure oxygen breathing versus air |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy non-smokers; patients undergoing CABG under cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Subjects with a pulmonary disease; subjects who have stayed at high altitude since at least 3 months; healthy subjects taking medication; patients undergoing a redo or combined cardiac surgery; patients with renal insufficiency; any emergency CABG; Patients with pulmonary disease
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 |
|---|---|---|
| pure oxygen breathing versus airone group will breath pure oxygen; the other will breath air | Other | oxygen, placebo |
Primary outcome
decrease in Troponin-I values
Time frame: 12h
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 19 Nov 2014.
- Background: PubMed 16239610Balestra C, Germonpre P, Poortmans JR, Marroni A. Serum erythropoietin levels in healthy humans after a short period of normobaric and hyperbaric oxygen breathing: the "normobaric oxygen paradox". J Appl Physiol (1985). 2006 Feb;100(2):512-8. doi: 10.1152/japplphysiol.00964.2005. Epub 2005 Oct 20.
- Background: PubMed 14523037Parsa CJ, Matsumoto A, Kim J, Riel RU, Pascal LS, Walton GB, Thompson RB, Petrofski JA, Annex BH, Stamler JS, Koch WJ. A novel protective effect of erythropoietin in the infarcted heart. J Clin Invest. 2003 Oct;112(7):999-1007. doi: 10.1172/JCI18200.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pure oxygen breathing versus air in people with Healthy and Coronary Artery Bypass Graft, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 19 Nov 2014. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
decrease in Troponin-I values (time frame: 12h). 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 NCT00824759, which also lists 2 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 19 Nov 2014.