Hypertension, Pulmonary
Conditions
Keywords
hypoxia, exercise, blood markers
Brief summary
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).
Interventions
Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil.
Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent as documented by signature (Appendix Informed Consent Form) * PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion criteria
* resting partial pressure of oxygen \<8 kilopascal at Zürich altitude on ambient air * exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study * inability to follow the procedures of the study * patients who take nitrates * other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of ferritin | Baseline | Analyis of serum levels of ferritin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of total iron | Baseline | Analysis of serum levels of total iron |
| Serum levels of erythropoietin | Baseline | Analysis of serum levels of erythropoietin |
| Serum levels of transferrin | Baseline | Analyis of serum levels of transferrin |
| Serum levels of hepcidin | Baseline | Analysis of serum levels of hepcidin |
| micro-RNA levels | Baseline | Analysis of micro-RNA levels |
| Serum levels of Erythroferrone | Baseline | Analysis of serum levels of erythroferrone |
Countries
Switzerland
Outcome results
None listed