Clinical trial NCT03637114: Acute Exposure of Simulated Hypoxia on Blood and Tissue Oxygenation (aBGA, NIRS)
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Simulated altitude
arterial blood gas analysis
near infrared spectroscopy
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Including a baseline assessment and assessments under simulated altitude and normoxia.
Primary purpose: PREVENTION

Brief summary: Randomized crossover trial in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) on blood and tissue oxygenation (ABGA, near infrared spectroscopy)

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 under simulated altitude (FiO2: 15.1% with the "AMC altitrainer") and shamed altitude with the same device.

At rest and under exercise data from ABGA and near infrared spectroscopy will be compared under simulated altitude and shamed altitude.

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 kilopascal (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, 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

Primary outcomes:
measure: arterial blood oxygenation under simulated altitude at rest (FiO2: 15.1)
timeFrame: 2 hours
measure: arterial blood oxygenation under simulated altitude at the time of exhaustion (FiO2: 15.1)
timeFrame: 2 hours
Secondary outcomes:
measure: Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)
timeFrame: 2 hours
measure: Near infrared spectroscopy under simulated altitude at rest (FiO2: 15.1)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Respiratory Clinic, University Hospital of Zurich
Study officials:
affiliation: University of Zurich
name: Silvia Ulrich, Prof.
role: PRINCIPAL_INVESTIGATOR
References: