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Completed

NCT Number: NCT05112172

Effect of Oxygen Therapy for Patients With Precapillary Pulmonary Hypertension Who Experience an Altitude Related Adverse Health Effect (ARAHE) During 30h Exposure to 2500m

To study whether oxygen therapy titrated to maintain oxygenation (SpO2) > 90% at 2500m would resolve altitude-related adverse health effects, symptoms and impaired exercise during 30h exposure to high altitude.

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Key information

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

About this study

Patients with pulmonary hypertension who reveal an altitude-related adverse health effects at 2500m will be given oxygen therapy by nasal cannula titrated to maintain the oxygen saturation above 90%. The study will investigate, whether this measure will restore altitude-induced impairment to baseline levels at low altitude.

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

Oxygen therapy

Other

Oxygen Therapy in patients developing an altitude related adverse health effect (ARAHE) during 30h exposure to 2500m of high altitude

Primary outcomes

  1. Recovery from ARAHE

    Time frame: 30 hours

    Proportion of patients with precapillary pulmonary hypertension experiencing an ARAHE at 2500 m of high altitude and receiving oxygen therapy titrated to achieve SpO2 ≥ 90% who recover from ARAHE, have improved symptoms and achieve constant work-rate exercise time within a minimal important difference as defined for patients with respiratory disease within 1.75 min of baseline value at 490 m; time frame within 6 h after initiation of oxygen therapy.

Secondary outcomes

  1. Constant work-rate exercise time

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude in constant work-rate exercise time cycle exercise test at 75% Wmax at low altitude

  2. Maximum work-rate in incremental ramp cycle exercise tests

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude in maximal exercise capacity during a incremental ramp cycle exercise test

  3. Hemodynamics

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude in hemodynamics assessed by echocardiography at rest including pulmonary artery pressure, cardiac output, pulmonary vascular resistance and right heart function assessed as tricuspid plane systolic excursion and fractional area change.

  4. Borg dyspnoea scale

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude baseline in post-exercise Borg dyspnoea scale going from 1-10 scores with higher values meaning worse dyspnea

  5. Visual Analogue Scale

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Visual Analogue Scale for dyspnoea, a 10cm line from left to right where patients have to add a cross-line with higher values meaning better feeling.

  6. Cognitive testing

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude baseline in cognitive function tests

  7. sit-to-stand test

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude baseline in sit-to-stand test

  8. Sleep disordered breathing

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude in sleep disordered breathing

  9. 6 minute walk test

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude in 6 minute walk test

  10. Acute Mountain Sickness Score

    Time frame: 30 hours

    Difference with oxygen therapy at high altitude vs. low altitude baseline in symptoms assessed by the Lake Louise acute mountain sickness score going from 0-12 points with mild AMS as 3-5 points, moderate AMS as 6-9 points, and severe AMS as 10-12 points.

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 8, 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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