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Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo) Under Exercise

Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03637179
Enrollment
28
Registered
2018-08-17
Start date
2018-07-01
Completion date
2019-01-01
Last updated
2020-01-07

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

Conditions

Pulmonary Hypertension

Keywords

High Altitude, Pulmonary artery pressure, Echocardiography, Right heart function, exercise

Brief summary

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (2500m above sea level) on pulmonary artery pressure and right heart function (Echo) under exercise.

Detailed description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis. Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m). Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo under exercise.

Interventions

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours

Sponsors

University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Crossover Assignment Including a baseline assessment and assessments at Low altitude and High altitude

Eligibility

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

Inclusion criteria

* Informed consent * PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis * PH class 1 (PAH) or 4 (CTEPH) * Stable condition, on the same medication for \> 4 weeks * Patient live permanently at an altitude \< 1000m asl.

Exclusion criteria

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * Severe daytime hypercapnia (pCO2 \> 6.5 kPa) * Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes. * Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation * Residence \> 1000m above sea level * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability * Women who are pregnant or breast feeding

Design outcomes

Primary

MeasureTime frameDescription
Echocardiographic Assessment at High Altitude (2500m) during exercise1 day at altitudePulmonary artery pressure will be measured by echo (TTE) under exercise.

Secondary

MeasureTime frameDescription
Echocardiographic right heart assessment at High Altitude (2500m) during exercise1 day at altitudeThe right heart function (fac, D-Shaping, etc.) will be assessed by echocardiography (TTE) under exercise

Countries

Switzerland

Outcome results

None listed

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