Acute Exposure of High Altitude on Cognitive Function

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Other: Säntis; 2500m above sea Level

• Registration Number: NCT03637192
• Lead Sponsor: University of Zurich

Brief Summary

Randomized crossover Trial in patients with pulmonary arterial hypertension (PAH) or chronic thromboembolic pulmonary Hypertension (CTEPH) to assess the acute response to High Altitude (2500m above sea level) on cognitive functions

Detailed Description

Low altitude baseline measurements will be performed in Zurich (460m) including Echocardiography, Right heart catheterization, 6 Minute walk test, 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 to High Altitude (Säntis; 2500m above sea level) for approximately 5 hour, the participants will perform cognitive function test .

The results will be compared to low altitude in Zurich (470m).

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Order B	Säntis; 2500m above sea Level	The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

Primary Outcome Measures

Name	Time	Method
Cognitive Function test	1 day at altitude	Change in cognitive function test time during the exposure to High altitude (Säntis ; 2500m above sea level) compared to low altitude (Zurich)

Trial Locations

Locations (1)

Respiratory Clinic, University Hospital of Zurich; 🇨🇭 Zurich, Switzerland