HEXA: Hemodynamic Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension
Study Details
Study Description
Brief Summary
To study hemodynamic effects of acute normobaric hypoxia during exercise in patients with pulmonary hypertension in a single-center randomized controlled trial.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Normobaric hypoxia (FiO2 15%)
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Other: Normobaric hypoxia (FiO2 15%)
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.
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Sham Comparator: Placebo-ambient air (FiO2 21%)
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Other: Placebo-ambient air (FiO2 21%)
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.
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Outcome Measures
Primary Outcome Measures
- 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
- Differences in pulmonary arterial pressure [2 hours]
Differences in pulmonary arterial pressure 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
- 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 right atrial pressure [2 hours]
Differences in right atrial pressure 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 heart rate [2 hours]
Differences in heart rate 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 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 muscle tissue oxygenation [2 hours]
Differences in muscle 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 symptoms (Borg leg effort) [2 hours]
Differences in symptoms (Borg leg effort) at rest and during exercise, with normoxia/hypoxia
Eligibility Criteria
Criteria
Inclusion Criteria:
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Informed consent as documented by signature (Appendix Informed Consent Form)
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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:
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resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air
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exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
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inability to follow the procedures of the study
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patients who take nitrates
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other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | UniversityHospital Zurich, Department of Pulmonology | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- University of Zurich
Investigators
- Principal Investigator: Silvia Ulrich, Prof. Dr., UniversityHospital Zurich, Department of Pulmonology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-02163_A1