Hemodynamic Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension
- Conditions
- Hypertension, Pulmonary
- Registration Number
- NCT04697875
- Lead Sponsor
- University of Zurich
- Brief Summary
To study hemodynamic effects of acute normobaric hypoxia during exercise in patients with pulmonary hypertension in a single-center randomized controlled trial.
- 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) 2 hours Difference in mPAP/CO during exercise between tests under hypoxia vs. normoxia
- Secondary Outcome Measures
Name Time Method Differences in right atrial pressure 2 hours Differences in right atrial pressure at rest and during exercise, with normoxia/hypoxia
Differences in blood pressure 2 hours Differences in blood pressure at rest and during exercise, with normoxia/hypoxia
Differences in pulmonary arterial pressure 2 hours Differences in pulmonary arterial pressure at rest and during exercise, with normoxia/hypoxia
Pulmonary vascular resistance 2 hours Differences in pulmonary vascular resistance at rest and during exercise, with normoxia/hypoxia
Differences in pulmonary artery wedge pressure 2 hours Differences in pulmonary artery wedge pressure at rest and during exercise, with normoxia/hypoxia
Differences in heart rate 2 hours Differences in heart rate at rest and during exercise, with normoxia/hypoxia
Differences in cardiac output 2 hours Differences in cardiac output at rest and during exercise, with normoxia/hypoxia
Differences in oxygen saturation 2 hours Differences in oxygen saturation at rest and during exercise, with normoxia/hypoxia
Differences in arterial blood gases 2 hours Differences in arterial blood gases at rest and during exercise, with normoxia/hypoxia
Differences in mixed venous blood gases 2 hours Differences in mixed venous blood gases at rest and during exercise, with normoxia/hypoxia
Differences in cerebral tissue oxygenation 2 hours Differences in cerebral tissue oxygenation at rest and during exercise, with normoxia/hypoxia
Differences in symptoms (Borg dyspnoea) 2 hours Differences in symptoms (Borg dyspnoea) at rest and during exercise, with normoxia/hypoxia
Differences in mixed venous oxygen saturation 2 hours Differences in mixed venous oxygen saturation at rest and during exercise, with normoxia/hypoxia
Differences in muscle tissue oxygenation 2 hours Differences in muscle tissue oxygenation at rest and during exercise, with normoxia/hypoxia
Differences in symptoms (Borg leg effort) 2 hours Differences in symptoms (Borg leg effort) at rest and during exercise, with normoxia/hypoxia
Trial Locations
- Locations (1)
UniversityHospital Zurich, Department of Pulmonology
🇨🇭Zurich, Switzerland
UniversityHospital Zurich, Department of Pulmonology🇨🇭Zurich, Switzerland