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Maximal Exercise Capacity at 2500 m of High Altitude

Primary Purpose

High Altitude Pulmonary Hypertension, Maximal Exercise Capacity

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Maximal Exercise Capacity
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for High Altitude Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent as documented by signature (Appendix Informed Consent Form)
  • 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

  • Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High altitude 2500 m above sea level (high altitude)

Low altitude 470 m above sea level (low altitude)

Arm Description

Maximum Exercise Capacity in high altitude

Maximum Exercise Capacity in low altitude

Outcomes

Primary Outcome Measures

Maximal work rate
Change in maximal work rate in Watt at 2500 vs. 490 m

Secondary Outcome Measures

Heart rate
Change in cardiorespiratory measurements: heart rate during a cycle incremental ramp exercise test at high altitude vs. low altitude
Ventilation
Change in cardiorespiratory measurements: ventilation during a cycle incremental ramp exercise test at high altitude vs. low altitude
Oxygen uptake
Change in cardiorespiratory measurements: Oxygen uptake, SpO2, blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude
Arterial blood oxygenation saturation
Change in cardiorespiratory measurements: Oxygenation (SpO2) during a cycle incremental ramp exercise test at high altitude vs. low altitude
Blood gases
Change in blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude
Hemodynamics
Change in hemodynamics assessed by echocardiography
Borg dyspnoea and leg fatigue scale
Change in post-exercise Borg dyspnoea and leg fatigue scale during a cycle incremental ramp exercise test at high altitude vs. low altitude
Visual Analogue Scale for dyspnea
Change Visual Analogue Scale at high altitude vs. low altitude according to a 10cm scale from left to right, where the subject has to mark dyspnea with higher values in cm meaning worse dyspnea
Electro cardiography
Prevalence of abnormal resting electro cardiography (ECG) at high altitude vs. low altitude
Electro cardiography :ST-segment changes
Difference in ST-segment changes during cycle incremental ramp and constant work-rate exercise tests at high altitude vs. low altitude
Electro cardiography: ST-segment changes under oxygen
7Difference in ST-segment changes during cycle exercise tests without and with oxygen at high altitude
Electro cardiography: Clinically relevant ischemia
Incidence of clinically relevant ischemia (>1mm ST-segment depression) during cycle exercise tests at high altitude vs. low altitude
Electro cardiography: QT-Interval
Change of corrected QT-Interval, during cycle exercise tests at high vs. low altitude
Electro cardiography: QT-Interval
Change of corrected QRS duration, during cycle exercise tests at high vs. low altitude
Electro cardiography: PQ-Interval
Change of corrected PQ-Interval, during cycle exercise tests at high vs. low altitude
Rate pressure product
Change of corrected Rate pressure product, during cycle exercise tests at high vs. low altitude
Electro cardiography: Cardiac arrhythmia
Incidence of cardiac arrhythmia during cycle exercise tests at high altitude vs. low altitude

Full Information

First Posted
October 14, 2021
Last Updated
May 10, 2022
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT05264324
Brief Title
Maximal Exercise Capacity at 2500 m of 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 20, 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 hypoxia on maximal work rate during incremental ramp exercise within 3-6 hours after arriving at 2500m of high altitude in patients with precapillary pulmonary hypertension

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Altitude Pulmonary Hypertension, Maximal Exercise Capacity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patients will be exposed to ambient air at 490m vs. hypoxic air at 2500m in a randomized sequence according to a cross-over design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High altitude 2500 m above sea level (high altitude)
Arm Type
Experimental
Arm Description
Maximum Exercise Capacity in high altitude
Arm Title
Low altitude 470 m above sea level (low altitude)
Arm Type
Active Comparator
Arm Description
Maximum Exercise Capacity in low altitude
Intervention Type
Procedure
Intervention Name(s)
Maximal Exercise Capacity
Intervention Description
Maximal Exercise Capacity in incremental ramp exercise tests.
Primary Outcome Measure Information:
Title
Maximal work rate
Description
Change in maximal work rate in Watt at 2500 vs. 490 m
Time Frame
30 hours
Secondary Outcome Measure Information:
Title
Heart rate
Description
Change in cardiorespiratory measurements: heart rate during a cycle incremental ramp exercise test at high altitude vs. low altitude
Time Frame
30 hours
Title
Ventilation
Description
Change in cardiorespiratory measurements: ventilation during a cycle incremental ramp exercise test at high altitude vs. low altitude
Time Frame
30 hours
Title
Oxygen uptake
Description
Change in cardiorespiratory measurements: Oxygen uptake, SpO2, blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude
Time Frame
30 hours
Title
Arterial blood oxygenation saturation
Description
Change in cardiorespiratory measurements: Oxygenation (SpO2) during a cycle incremental ramp exercise test at high altitude vs. low altitude
Time Frame
30 hours
Title
Blood gases
Description
Change in blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude
Time Frame
30 hours
Title
Hemodynamics
Description
Change in hemodynamics assessed by echocardiography
Time Frame
30 hours
Title
Borg dyspnoea and leg fatigue scale
Description
Change in post-exercise Borg dyspnoea and leg fatigue scale during a cycle incremental ramp exercise test at high altitude vs. low altitude
Time Frame
30 hours
Title
Visual Analogue Scale for dyspnea
Description
Change Visual Analogue Scale at high altitude vs. low altitude according to a 10cm scale from left to right, where the subject has to mark dyspnea with higher values in cm meaning worse dyspnea
Time Frame
30 hours
Title
Electro cardiography
Description
Prevalence of abnormal resting electro cardiography (ECG) at high altitude vs. low altitude
Time Frame
30 hours
Title
Electro cardiography :ST-segment changes
Description
Difference in ST-segment changes during cycle incremental ramp and constant work-rate exercise tests at high altitude vs. low altitude
Time Frame
30 hours
Title
Electro cardiography: ST-segment changes under oxygen
Description
7Difference in ST-segment changes during cycle exercise tests without and with oxygen at high altitude
Time Frame
30 hours
Title
Electro cardiography: Clinically relevant ischemia
Description
Incidence of clinically relevant ischemia (>1mm ST-segment depression) during cycle exercise tests at high altitude vs. low altitude
Time Frame
30 hour
Title
Electro cardiography: QT-Interval
Description
Change of corrected QT-Interval, during cycle exercise tests at high vs. low altitude
Time Frame
30 hours
Title
Electro cardiography: QT-Interval
Description
Change of corrected QRS duration, during cycle exercise tests at high vs. low altitude
Time Frame
30 hours
Title
Electro cardiography: PQ-Interval
Description
Change of corrected PQ-Interval, during cycle exercise tests at high vs. low altitude
Time Frame
30 hours
Title
Rate pressure product
Description
Change of corrected Rate pressure product, during cycle exercise tests at high vs. low altitude
Time Frame
30 hours
Title
Electro cardiography: Cardiac arrhythmia
Description
Incidence of cardiac arrhythmia during cycle exercise tests 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 (Appendix Informed Consent Form) 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
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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Maximal Exercise Capacity at 2500 m of High Altitude

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