Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without Sildenafil
- Conditions
- Hypertension, Pulmonary
- Registration Number
- NCT04704440
- Lead Sponsor
- University of Zurich
- Brief Summary
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method mean pulmonary artery pressure (mPAP) / cardiac output (CO) 4 hours Difference in mPAP/CO during exercise between tests under normoxia/hypoxia with/without Sildenafil
- Secondary Outcome Measures
Name Time Method Differences in right atrial pressure 4 hours Differences in right atrial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in pulmonary artery wedge pressure 4 hours Differences in pulmonary artery wedge pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in oxygen saturation 4 hours Differences in oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in arterial blood gases 4 hours Differences in arterial blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in cerebral tissue oxygenation 4 hours Differences in cerebral tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil
Differences in symptoms (Borg dyspnoea) 4 hours Differences in symptoms (Borg dyspnoea) at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in muscle tissue oxygenation 4 hours Differences in muscle tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil
Differences in symptoms (Borg leg effort) 4 hours Differences in symptoms (Borg leg effort) at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in pulmonary arterial pressure 4 hours Differences in pulmonary arterial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in cardiac output 4 hours Differences in cardiac output at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in pulmonary vascular resistance 4 hours Differences in pulmonary vascular resistance at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in mixed venous oxygen saturation 4 hours Differences in mixed venous oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in heart rate 4 hours Differences in heart rate at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in mixed venous blood gases 4 hours Differences in mixed venous blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in blood pressure 4 hours Differences in blood pressure at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Trial Locations
- Locations (1)
University Hospital of Zurich
🇨🇭Zurich, Switzerland
University Hospital of Zurich🇨🇭Zurich, Switzerland