Acute Exposure to High Altitude on Exercise Capacity

NCT03637153 | Completed

• 1 other identifier: 2018-00455_B1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

exercise capacity; High Altitude; contant loaded exercise test

Outcome Measures

Primary Outcomes (1)

• endurance time at High Altitude

  The time of a constant loaded exercise test by an ergometer in sitting position at High Altitude will be compared with the same test at low altitude (370m above sea level)

  1 day at altitude

Study Arms (2)

Order A

EXPERIMENTAL

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).

Other: Assessment at Low Altitude (470m above sea level); Other: Exposure to High Altitude (2500m above sea level)

Order B

EXPERIMENTAL

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).

Other: Assessment at Low Altitude (470m above sea level); Other: Exposure to High Altitude (2500m above sea level)

Interventions

Assessment at Low Altitude (470m above sea level) OTHER

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

Order A; Order B

Exposure to High Altitude (2500m above sea level) OTHER

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

Order A; Order B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35628896 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Altitude Sickness

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders

Study Officials

• Silvia Ulrich, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Including a baseline assessment and assessments at Low altitude and High altitude

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 17, 2018
• Study Start: July 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CH (1)