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Acute Exposure to High Altitude on Exercise Capacity

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ClinicalTrials.gov Identifier: NCT03637153
Recruitment Status : Completed
First Posted : August 17, 2018
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Other: Assessment at Low Altitude (470m above sea level) Other: Exposure to High Altitude (2500m above sea level) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Including a baseline assessment and assessments at Low altitude and High altitude
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Actual Study Start Date : July 1, 2018
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Other: 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

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

Experimental: 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).
Other: 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

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




Primary Outcome Measures :
  1. endurance time at High Altitude [ Time Frame: 1 day at 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637153


Locations
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Switzerland
Respiratory Clinic, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich, Prof. University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03637153    
Other Study ID Numbers: 2018-00455_B1
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
exercise capacity
High Altitude
contant loaded exercise test
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases