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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05131737
Enrollment
28
Registered
2021-11-23
Start date
2021-10-18
Completion date
2022-04-15
Last updated
2022-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude Pulmonary Hypertension

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

Interventions

PROCEDUREHigh altitude exposure

Exposure to 2500m of altitude

PROCEDURELow altitude exposure

Exposure to 490 m

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
cycle constant work-rate exercise test30 hoursDifference in cycle constant work-rate exercise test (CWRET) time at 2500 vs. 490 m (Time Frame 24 to 30 hours)

Secondary

MeasureTime frameDescription
Ventilation in liters per minute30 hoursDifference 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
Visual analogue scale30 hoursDifference in baseline in symptoms assessed by the Visual Analogue Scale at high altitude vs. low altitude
Oxygen uptake30 hoursDifference in cardiorespiratory measurements: oxygen uptake, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Oxygen saturation30 hoursDifference in cardiorespiratory measurements: Oxygen saturation, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Heart rate30 hoursDifference in cardiorespiratory measurements: Heart rate, during a cycle constant work-rate exercise test (CWRET) time at high altitude vs. low altitude
Tricuspid pressure gradient30 hoursTrans-tricuspid pressure gradient by echocardiography
Borg dyspnoea scale30 hoursDifference 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
sit-to-stand test frequency30 hoursDifference 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 test30 hoursDifference in baseline in 6 minute walk test distance at high altitude vs. low altitude
Partial pressure or oxygen30 hoursDifference 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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026