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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 non-invasive cardiac output assessments by Finapres® "NOVA" Technology at rest and under exercise.
Low altitude baseline measurements will be performed in Zurich (470m asl) including Echocardiography, right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise.
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.
During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants cardiac output non-invasively assessed will be measured throughout the whole intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Order Sham/Hypoxia | Experimental | The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask. |
|
| Order Hypoxia/Sham | Experimental | The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer", SMTEC) with a facemask. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simulated Altitude (FiO2: 15.1) | Device | Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Output measured non-invasively | Change in non-invasive assessed cardiac output measured with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich, MD | 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 |
| D009043 | Motor Activity |
| 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 trough 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 |
| D001519 | Behavior |