Pulmonary Hypertension
Conditions
Keywords
High Altitude, non-invasive cardiac output, Finapres
Brief summary
Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response High Altitude (Säntis; 2500m above sea level) on non-invasive cardiac output assessments by Finapres® NOVA Technology at rest and under exercise
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). During the exposure High Altitude (2500m) and Low Altitude (Zurich; 470m) up to 5 hours, the participants cardiac output non-invasively assessed will be measured repetitive during the whole intervention.
Interventions
Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Including a baseline assessment and assessments at Low altitude and High altitude
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Output measured non-invasively | Averaged over two minutes rest and 30 seconds end of exercise (exhaustion) | Change in non-invasive assessed cardiac output measured with a finger cuff (Finapres) during the exposure to High Altitude (2500m) compared to Low Altitude (Zurich; 470m) |
Countries
Switzerland
Outcome results
None listed