Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Arterial blood oxygenation at High Altitude (2500m above sea level)
Study Overview
Brief Summary
Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on blood and tissue oxygenation (ABGA, NIRS).
Detailed Description
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.
Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).
At rest and under exercise data from ABGA and NIRS will be compared at low altitude and High Altitude.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent
- •PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
- •PH class 1 (PAH) or 4 (CTEPH)
- •Stable condition, on the same medication for > 4 weeks
- •Patient live permanently at an altitude < 1000m asl.
Exclusion Criteria
- •Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
- •Severe daytime hypercapnia (pCO2 > 6.5 kPa)
- •Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
- •Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
- •Residence > 1000m above sea level
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
- •Women who are pregnant or breast feeding
Outcomes
Primary Outcomes
Arterial blood oxygenation at High Altitude (2500m above sea level)
Time Frame: within 5 hours
Difference in arterial blood oxygenation at Low Altitude (Zurich, 470m above sea level) and High Altitude (Säntis; 2500m above sea level)
Secondary Outcomes
- Near infrared spectroscopy at High Altitude (2500m)(within 5 hours)