An interventional study of Simulated Altitude (FiO2: 15.1) and Shamed Hypoxia (FiO2: 20.9) in Pulmonary Hypertension, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by University of Zurich · Not applicable, Interventional, and Prevention
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 28 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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Exclusion Criteria:
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.
Device: Simulated Altitude (FiO2: 15.1) · Device: Shamed Hypoxia (FiO2: 20.9)
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.
Device: Simulated Altitude (FiO2: 15.1) · Device: Shamed Hypoxia (FiO2: 20.9)
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
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
Time frame: 1 hour
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of Zurich