Cardioprotective Effects of Increased Endogenous Erythropoietin After Normobaric Oxygen Breathing

This study is not yet open for participant recruitment.

Verified by Cliniques universitaires Saint-Luc- Université Catholique de Louvain, January 2009

First Received: January 16, 2009 Last Updated: January 19, 2009 History of Changes

Sponsored by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by:	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:	NCT00824759

Purpose

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.

Condition	Intervention
Healthy Coronary Artery Bypass Graft	Other: pure oxygen breathing versus air

MedlinePlus related topics: Coronary Artery Bypass Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:

decrease in Troponin-I values [ Time Frame: 12h ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator	Other: pure oxygen breathing versus air one group will breath pure oxygen; the other will breath air
oxygen: Active Comparator	Other: pure oxygen breathing versus air one group will breath pure oxygen; the other will breath air

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy non-smokers; patients undergoing CABG under cardiopulmonary bypass

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824759

Contacts

Contact: MONA MOMENI, MD	+32.2764.7029 ext 8am-6pm	mona.momeni@uclouvain.be
Contact: GIUSEPPE LIISTRO, MD,PhD		giuseppe.liistro@uclouvain.be

Locations

Belgium
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

More Information

Publications:

Balestra C, Germonpré 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. 2006 Feb;100(2):512-8. Epub 2005 Oct 20.

Parsa 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.

Responsible Party:	Cliniques Universitaires Saint Luc ( MONA MOMENI, MD )
Study ID Numbers:	2008/24NOV/331
Study First Received:	January 16, 2009
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00824759 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Healthy subjects
CABG
Patients undergoing coronary artery bypass graft under cardiopulmonary bypass

Study placed in the following topic categories:

Epoetin Alfa
Healthy

ClinicalTrials.gov processed this record on May 07, 2009