Back to resultsExercise Endurance Time on the 2nd Day at 2500 m High Altitude
Primary Purpose
High Altitude Pulmonary Hypertension
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
High altitude exposure
Low altitude exposure
Sponsored by
About this trial
This is an interventional screening trial for High Altitude Pulmonary Hypertension
Eligibility Criteria
Inclusion Criteria:
- Informed consent as documented by signature
- PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion Criteria:
- resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
- exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- inability to follow the procedures of the study
- other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Sites / Locations
- University Hospital of Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Constant work-rate at altitude 2500 m above sea level (high altitude)
Constant work-rate at altitude 470 m above sea level (low altitude)
Arm Description
Cycling at high altitude
Cycling at low altitude
Outcomes
Primary Outcome Measures
cycle constant work-rate exercise test
Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)
Secondary Outcome Measures
Heart rate
Difference in cardiorespiratory measurements: Heart rate, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Ventilation in liters per minute
Difference in cardiorespiratory measurements: Ventilation assessed in liters per minute, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Oxygen uptake
Difference in cardiorespiratory measurements: oxygen uptake, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Oxygen saturation
Difference in cardiorespiratory measurements: Oxygen saturation, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Partial pressure or oxygen
Difference in partial pressure of oxygen at the beginning and end of a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Tricuspid pressure gradient
Trans-tricuspid pressure gradient by echocardiography
Borg dyspnoea scale
Difference in post-exercise Borg dyspnoea and leg fatigue scale during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Visual analogue scale
Difference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude
sit-to-stand test frequency
Difference in baseline in sit-to-stand test frequency of standing up from a chair in a minute at high altitude vs. low altitude
6 minute walk test
Difference in baseline in 6 minute walk test distance at high altitude vs. low altitude
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05131737
Brief Title
Exercise Endurance Time on the 2nd Day at 2500 m High Altitude
Official Title
The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 18, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension
Detailed Description
Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Pulmonary Hypertension
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Constant work-rate at altitude 2500 m above sea level (high altitude)
Arm Type
Experimental
Arm Description
Cycling at high altitude
Arm Title
Constant work-rate at altitude 470 m above sea level (low altitude)
Arm Type
Active Comparator
Arm Description
Cycling at low altitude
Intervention Type
Procedure
Intervention Name(s)
High altitude exposure
Intervention Description
Exposure to 2500m of altitude
Intervention Type
Procedure
Intervention Name(s)
Low altitude exposure
Intervention Description
Exposure to 490 m
Primary Outcome Measure Information:
Title
cycle constant work-rate exercise test
Description
Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)
Time Frame
30 hours
Secondary Outcome Measure Information:
Title
Heart rate
Description
Difference in cardiorespiratory measurements: Heart rate, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Time Frame
30 hours
Title
Ventilation in liters per minute
Description
Difference in cardiorespiratory measurements: Ventilation assessed in liters per minute, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Time Frame
30 hours
Title
Oxygen uptake
Description
Difference in cardiorespiratory measurements: oxygen uptake, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Time Frame
30 hours
Title
Oxygen saturation
Description
Difference in cardiorespiratory measurements: Oxygen saturation, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Time Frame
30 hours
Title
Partial pressure or oxygen
Description
Difference in partial pressure of oxygen at the beginning and end of a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Time Frame
30 hours
Title
Tricuspid pressure gradient
Description
Trans-tricuspid pressure gradient by echocardiography
Time Frame
30 hours
Title
Borg dyspnoea scale
Description
Difference in post-exercise Borg dyspnoea and leg fatigue scale during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Time Frame
30 hours
Title
Visual analogue scale
Description
Difference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude
Time Frame
30 hours
Title
sit-to-stand test frequency
Description
Difference in baseline in sit-to-stand test frequency of standing up from a chair in a minute at high altitude vs. low altitude
Time Frame
30 hours
Title
6 minute walk test
Description
Difference in baseline in 6 minute walk test distance at high altitude vs. low altitude
Time Frame
30 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent as documented by signature
PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Exclusion Criteria:
resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
inability to follow the procedures of the study
other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Exercise Endurance Time on the 2nd Day at 2500 m High Altitude
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