Acute Exposure to High Altitude on Exercise Capacity

NCT ID: NCT03637153

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2019-01-01

Brief Summary

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) in constant loaded exercise capacity.

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).

Towards the end of the exposure after approximately 4 hours, the participants will perform a constant loaded exercise test on an Ergometer with a calculated resistance of their 60% max Workload.

The patients will be encouraged to perform these tests up to their physical exhaustion.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Order A

Firstly, the participants will have their assessments at low altitude (Low altitude: 470m above sea level) in Zurich and consecutively the exposure to High Altitude (Säntis; 2500m above sea Level).

Group Type: EXPERIMENTAL

Assessment at Low Altitude (470m above sea level)

Intervention Type: OTHER

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Exposure to High Altitude (2500m above sea level)

Intervention Type: OTHER

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Order B

Firstly, the participants will exposed to High Altitude (Säntis; 2500m above sea level) and consecutively will they have assessement in Zurich (Low altitude; 470m above sea level).

Group Type: EXPERIMENTAL

Assessment at Low Altitude (470m above sea level)

Intervention Type: OTHER

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Exposure to High Altitude (2500m above sea level)

Intervention Type: OTHER

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Interventions

Assessment at Low Altitude (470m above sea level)

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Intervention Type: OTHER

Exposure to High Altitude (2500m above sea level)

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Silvia Ulrich, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Respiratory Clinic, University Hospital of Zurich

Zurich, , Switzerland

Countries

Switzerland

References

Schneider SR, Lichtblau M, Furian M, Mayer LC, Berlier C, Muller J, Saxer S, Schwarz EI, Bloch KE, Ulrich S. Cardiorespiratory Adaptation to Short-Term Exposure to Altitude vs. Normobaric Hypoxia in Patients with Pulmonary Hypertension. J Clin Med. 2022 May 14;11(10):2769. doi: 10.3390/jcm11102769.

Reference Type: DERIVED

PMID: 35628896 (View on PubMed)

Other Identifiers

2018-00455_B1

Identifier Type: -

Identifier Source: org_study_id