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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) in constant loaded exercise capacity.
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.
Towards the end of the exposure after approximately 1h, the participants will perform a constant loaded exercise test on an Ergometer with a calculated resistance of their 60% max. workload.
The patients will be encouraged to perform this test up to their physical exhaustion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order A | 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 B | 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 |
|---|---|---|
| Endurance time under hypoxia (FiO2: 15.1%) | Constant loaded exercise test | Towards the end of a one hour exposure |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35628896 | Derived | Schneider SR, Lichtblau M, Furian M, Mayer LC, Berlier C, Muller J, Saxer S, Schwarz EI, Bloch KE, Ulrich S. Cardiorespiratory Adaptation to Short-Term Exposure to Altitude vs. Normobaric Hypoxia in Patients with Pulmonary Hypertension. J Clin Med. 2022 May 14;11(10):2769. doi: 10.3390/jcm11102769. | |
| 32918899 | Derived |
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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 |
|
| Schneider SR, Mayer LC, Lichtblau M, Berlier C, Schwarz EI, Saxer S, Furian M, Bloch KE, Ulrich S. Effect of Normobaric Hypoxia on Exercise Performance in Pulmonary Hypertension: Randomized Trial. Chest. 2021 Feb;159(2):757-771. doi: 10.1016/j.chest.2020.09.004. Epub 2020 Sep 9. |
| D002318 |
| Cardiovascular Diseases |