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Completed

NCT Number: NCT05131737

Exercise Endurance Time on the 2nd Day at 2500 m High Altitude

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

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Key information

Conditions

High Altitude Pulmonary Hypertension Pulmonary edema of mountaineers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Zurich

Zurich, 8091, Switzerland

About this study

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

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
  • 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

High altitude exposure

Procedure

Exposure to 2500m of altitude

Low altitude exposure

Procedure

Exposure to 490 m

Primary outcomes

  1. cycle constant work-rate exercise test

    Time frame: 30 hours

    Difference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)

Secondary outcomes

  1. Heart rate

    Time frame: 30 hours

    Difference in cardiorespiratory measurements: Heart rate, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude

  2. Ventilation in liters per minute

    Time frame: 30 hours

    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

  3. Oxygen uptake

    Time frame: 30 hours

    Difference in cardiorespiratory measurements: oxygen uptake, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude

  4. Oxygen saturation

    Time frame: 30 hours

    Difference in cardiorespiratory measurements: Oxygen saturation, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude

  5. Partial pressure or oxygen

    Time frame: 30 hours

    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

  6. Tricuspid pressure gradient

    Time frame: 30 hours

    Trans-tricuspid pressure gradient by echocardiography

  7. Borg dyspnoea scale

    Time frame: 30 hours

    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

  8. Visual analogue scale

    Time frame: 30 hours

    Difference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude

  9. sit-to-stand test frequency

    Time frame: 30 hours

    Difference in baseline in sit-to-stand test frequency of standing up from a chair in a minute at high altitude vs. low altitude

  10. 6 minute walk test

    Time frame: 30 hours

    Difference in baseline in 6 minute walk test distance 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
Nov 23, 2021
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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