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Completed

NCT Number: NCT05264324

Maximal Exercise Capacity at 2500 m of High Altitude

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

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Key information

Conditions

High Altitude Pulmonary Hypertension Maximal Exercise Capacity Pulmonary edema of mountaineers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Maximal Exercise Capacity

Procedure

Maximal Exercise Capacity in incremental ramp exercise tests.

Primary outcomes

  1. Maximal work rate

    Time frame: 30 hours

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

Secondary outcomes

  1. Heart rate

    Time frame: 30 hours

    Change in cardiorespiratory measurements: heart rate during a cycle incremental ramp exercise test at high altitude vs. low altitude

  2. Ventilation

    Time frame: 30 hours

    Change in cardiorespiratory measurements: ventilation during a cycle incremental ramp exercise test at high altitude vs. low altitude

  3. Oxygen uptake

    Time frame: 30 hours

    Change in cardiorespiratory measurements: Oxygen uptake, SpO2, blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude

  4. Arterial blood oxygenation saturation

    Time frame: 30 hours

    Change in cardiorespiratory measurements: Oxygenation (SpO2) during a cycle incremental ramp exercise test at high altitude vs. low altitude

  5. Blood gases

    Time frame: 30 hours

    Change in blood gases during a cycle incremental ramp exercise test at high altitude vs. low altitude

  6. Hemodynamics

    Time frame: 30 hours

    Change in hemodynamics assessed by echocardiography

  7. Borg dyspnoea and leg fatigue scale

    Time frame: 30 hours

    Change in post-exercise Borg dyspnoea and leg fatigue scale during a cycle incremental ramp exercise test at high altitude vs. low altitude

  8. Visual Analogue Scale for dyspnea

    Time frame: 30 hours

    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

  9. Electro cardiography

    Time frame: 30 hours

    Prevalence of abnormal resting electro cardiography (ECG) at high altitude vs. low altitude

  10. Electro cardiography :ST-segment changes

    Time frame: 30 hours

    Difference in ST-segment changes during cycle incremental ramp and constant work-rate exercise tests at high altitude vs. low altitude

  11. Electro cardiography: ST-segment changes under oxygen

    Time frame: 30 hours

    7Difference in ST-segment changes during cycle exercise tests without and with oxygen at high altitude

  12. Electro cardiography: Clinically relevant ischemia

    Time frame: 30 hour

    Incidence of clinically relevant ischemia (>1mm ST-segment depression) during cycle exercise tests at high altitude vs. low altitude

  13. Electro cardiography: QT-Interval

    Time frame: 30 hours

    Change of corrected QT-Interval, during cycle exercise tests at high vs. low altitude

  14. Electro cardiography: QT-Interval

    Time frame: 30 hours

    Change of corrected QRS duration, during cycle exercise tests at high vs. low altitude

  15. Electro cardiography: PQ-Interval

    Time frame: 30 hours

    Change of corrected PQ-Interval, during cycle exercise tests at high vs. low altitude

  16. Rate pressure product

    Time frame: 30 hours

    Change of corrected Rate pressure product, during cycle exercise tests at high vs. low altitude

  17. Electro cardiography: Cardiac arrhythmia

    Time frame: 30 hours

    Incidence of cardiac arrhythmia during cycle exercise tests at high altitude vs. low altitude

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

The Impact of Hypoxia on Patients With Precapillary Pulmonary Hypertension and Treatment of Adverse Effects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2022
Registry last updated
May 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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