Hypertension, Pulmonary
Conditions
Keywords
hypoxia, exercise, hemodynamics, Vasodilative drug
Brief summary
To study hemodynamic effects of Sildenafil during exercise in patients with pulmonary hypertension.
Interventions
OTHERHemodynamic effect of 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.
OTHERHemodynamic effect of 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.
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
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 |
|---|---|---|
| mean pulmonary artery pressure (mPAP) / cardiac output (CO) | 4 hours | Difference in mPAP/CO during exercise between tests under normoxia with/without Sildenafil |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in cardiac output | 4 hours | Differences in cardiac output at rest and during exercise under normoxia with/without Sildenafil |
| Differences in pulmonary vascular resistance | 4 hours | Differences in pulmonary vascular resistance at rest and during exercise under normoxia with/without Sildenafil |
| Differences in pulmonary artery wedge pressure | 4 hours | Differences in pulmonary artery wedge pressure at rest and during exercise under normoxia with/without Sildenafil |
| Differences in right atrial pressure | 4 hours | Differences in right atrial pressure at rest and during exercise under normoxia with/without Sildenafil |
| Differences in mixed venous oxygen saturation | 4 hours | Differences in mixed venous oxygen saturation at rest and during exercise under normoxia with/without Sildenafil |
| Differences in heart rate | 4 hours | Differences in heart rate at rest and during exercise, under normoxia with/without Sildenafil |
| Differences in blood pressure (systolic and diastolic) | 4 hours | Differences in blood pressure (systolic and diastolic) at rest and during exercise, under normoxia with/without Sildenafil |
| Differences in pulmonary arterial pressure | 4 hours | Differences in pulmonary arterial pressure at rest and during exercise under normoxia with/without Sildenafil |
| Differences in arterial blood gases | 4 hours | Differences in arterial blood gases at rest and during exercise under normoxia with/without Sildenafil |
| Differences in mixed venous blood gases | 4 hours | Differences in mixed venous blood gases at rest and during exercise under normoxia with/without Sildenafil |
| Differences in cerebral tissue oxygenation | 4 hours | Differences in cerebral tissue oxygenation at rest and during exercise, under normoxia with/without Sildenafil |
| Differences in muscle tissue oxygenation | 4 hours | Differences in muscle tissue oxygenation at rest and during exercise, under normoxia with/without Sildenafil |
| Differences in symptoms (Borg dyspnoea) | 4 hours | Differences in symptoms (Borg dyspnoea, Borg CR10, scale 0-10) at rest and during exercise under normoxia with/without Sildenafil |
| Differences in symptoms (leg effort) | 4 hours | Differences in symptoms (leg effort, scale 0-10, 10 is maximal exhaustion) at rest and during exercise under normoxia with/without Sildenafil |
| Differences in oxygen saturation | 4 hours | Differences in oxygen saturation at rest and during exercise, under normoxia with/without Sildenafil |
Countries
Switzerland
Outcome results
None listed