Healthy Subjects
Conditions
Interventions
Group 1: Normobaric hypoxia:
Study day with 6-hour hypoxia (NH)
The examination is carried out in an altitude chamber.
Before entering the altitude chamber, blood is taken from the subjects.
They star
Sponsors
Deutsches Zentrum für Luft- und Raumfahrt Institut für Luft- und Raumfahrtmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy adults, 18 - 65 years old, without previous illnesses. Willingness to take a single weight-adapted dose of roxadustat (3mg/kg bw) in the absence of a hypoxia response = non-responder.
Exclusion criteria
Exclusion criteria: Altitude > 2000 meters or long-haul flight 3 months before the first day of study study day - Claustrophobia - Medication with hypnotics - Chronic fibrosing liver disease (Child-Pugh B / C) - History of deep vein thrombosis or pulmonary embolism Stroke or myocardial infarction Epilepsy or other seizure disorders - Hyperkalemia - Acute bacterial or viral infection - Iron deficiency - Iron storage disorders - Erythrocytosis - Pregnancy and breastfeeding - High blood pressure - Pulmonary hypertension - Tubal dysfunction with lack of pressure equalization - History of increased intraocular pressure - History of spontaneous pneumothorax or lung surgery - Peanut or soy allergy - Regular intake of statins - Hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the comparison of HIF accumulation between exposure to NH and HIF accumulation to HH. For each subject, the difference between the HIF accumulation after NH and HH and the individual normoxic baseline value is calculated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Delta of changes in the following HIF-induced proteins after NH and HH: Erythropoietin, VEGF, ANG1 and ANG2, IL8, ADM Differences in the number, size and content of extracellular vesicles (EZVs, NTA, MACSPlex, proteomics and miRNA analyses). Delta of change in nitrate and nitrite concentration in plasma (NO metabolites). Differences in the change in blood coagulation (thrombelastometry). Delta of the change in oxygen saturation in peripheral blood, measured with photoplethysmography on the finger. Delta of the change in oxygen saturation in the peripheral blood, measured in arterialized capillary blood (ABL-90). Delta of changes in cerebral oxygen saturation (rSPO2) measured with near infrared spectroscopy at the finger. infrared spectroscopy at the head (NIRS). Delta of change in heart rate measured by ECG. Delta of change in respiratory rate. Delta of change in systolic upper arm blood pressure. Delta of change in diastolic upper arm blood pressure. Changes in the metabolites of fatty acid and carbohydrate metabolism (Metabolomics, single blood drop; LC-MSMS, Prof. Stefan Kempa, MDC Berlin). Differences in gene expression (RNAseq, University of Bonn). Changes in single cell RNA profiles in peripheral mononuclear cells (Prof. Dmitry Tsvetkov, University of Greifswald). Correlations of parameter changes under NH and HH with cardiac parameters measured under normoxic parameters of cardiac function measured under normoxic resting conditions (echocardiography). Correlations of changes under NH and HH with maximum oxygen uptake measured under normoxic resting conditions. maximum oxygen uptake measured under normoxic resting conditions. Correlations of changes under NH and HH with physical activity (questionnaire). Differences in the modified Lake Louise Score under NH and HH (Acute Mountain Score, AMS). | — |
Countries
Germany
Contacts
Public ContactStilla Frede
Klinik für Anästhesiologie und oprative Intensivmedizin, Universitätsklinikum Bonn
Outcome results
None listed