Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo)

Study Overview
=================
Brief Summary
-----------------
Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (Säntis; 2500m above sea level) on pulmonary artery pressure and right heart function (echo)

Detailed Description
-----------------
Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (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). Several times within the exposure, the pulmonary artery pressure (PAP) and the right heart function will be assessed by echo.

Official Title
-----------------
Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Other: Assessment at Low Altitude (470m above sea level)
* Other: Exposure to High Altitude (2500m above sea level)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (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 partial Oxygen pressure (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 kilopascal (kPa)) Susceptibility to high altitude related diseases (AMS, high-altitude pulmonary edema (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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Including a baseline assessment and assessments at Low altitude and High altitude
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Order A<br>The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level) | Other: Assessment at Low Altitude (470m above sea level)<br>* Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure<br>Other: Exposure to High Altitude (2500m above sea level)<br>* Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours<br>|
| Experimental: Order B<br>The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level). | Other: Assessment at Low Altitude (470m above sea level)<br>* Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure<br>Other: Exposure to High Altitude (2500m above sea level)<br>* Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic assessment at High Altitude (2500m above sea level) | Pulmonary artery pressure will be measured by echo (TTE). | 1 day at altitude | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Echocardiographic right heart assessment at High Altitude (2500m above sea level) | The right heart function (fac, D-Shaping, etc.) will be assessed by Echocardiography (TTE) | 1 day at altitude | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High Altitude, Pulmonary artery pressure, Echocardiography, Right heart function