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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 ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.
Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking 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 e 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' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.
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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 |
|---|---|---|
| Non-invasive blood pressure (Finapres) | Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiography | Change in cardiac repolarization 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 |