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Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on pulmonary artery pressure and right heart function (Echo).
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.
Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo.
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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 |
|---|---|---|
| Echocardiographic assessment under hypoxia (FiO2: 15.1) | Pulmonary artery pressure measured by echo (TTE) | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Echocardiographic assessment of the right heart under hypoxia (FiO2: 15.1) | Right heart functions measured by echo (TTE) (fac, d-shaping, kinetic etc.) | 2 hours |
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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 |
|
| D002318 |
| Cardiovascular Diseases |