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Randomized crossover trial in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on blood and tissue oxygenation (ABGA, near infrared spectroscopy)
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis.
Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC altitrainer") and shamed altitude with the same device.
At rest and under exercise data from ABGA and near infrared spectroscopy will be compared under simulated altitude and shamed altitude.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order air-hypoxia | Experimental | The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator ("Altitrainer, SMTEC"), simulated altitude (FiO2: 15.1%), with a facemask. |
|
| Order hypoxia-air | Experimental | The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator ("Altitrainer, SMTEC") with a facemask. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulated Altitude (FiO2: 15.1%) | Device | Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask. |
|
| Measure | Description | Time Frame |
|---|---|---|
| arterial blood oxygenation under simulated altitude at rest (FiO2: 15.1) | Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest. | 2 hours |
| arterial blood oxygenation under simulated altitude at the time of exhaustion (FiO2: 15.1) | Difference in arterial blood oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at the time of exhaustion | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1) | Difference in cerebral tissue oxygenation and muscle tissue oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) at rest | 2 hours |
| Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, Prof. | University of Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinic, University Hospital of Zurich | Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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Including a baseline assessment and assessments under simulated altitude and normoxia.
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The allocated gas mixture will not be disclosed to the patient since he will breath through a facemask during both interventions.
| Shamed Hypoxia (FiO2: 20.9) | Device | Inhalation of unmodified air through an altitude Simulator ("Altitrainer") for approximately 1 hour given by a facemask |
|
Difference in cerebral tissue oxygenation and muscle tissue oxygenation under simulated altitude (FiO2: 15.1%) and shamed hypoxia (FiO2: 20.9%) |
| 2 hours |
| D002318 |
| Cardiovascular Diseases |