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CompletedNCT03637179Updated Jan 7, 2020

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

An interventional study of Assessment at Low Altitude (470m above sea level) and Exposure to High Altitude (2500m above sea level) in Pulmonary Hypertension, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-07.

Sponsored by University of Zurich · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • High Altitude
  • Pulmonary artery pressure
  • Echocardiography
  • Right heart function
  • exercise
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 28 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Order A

    The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)

    Other: Assessment at Low Altitude (470m above sea level) · Other: Exposure to High Altitude (2500m above sea level)

  • Experimental
    Order B

    The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

    Other: Assessment at Low Altitude (470m above sea level) · Other: Exposure to High Altitude (2500m above sea level)

Interventions

  • OtherAssessment at Low Altitude (470m above sea level)

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

  • OtherExposure to High Altitude (2500m above sea level)

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

06

What researchers measure

Primary outcomes

  1. Echocardiographic Assessment at High Altitude (2500m) during exercise

    Pulmonary artery pressure will be measured by echo (TTE) under exercise.

    Time frame: 1 day at altitude

Secondary outcomes

  1. Echocardiographic right heart assessment at High Altitude (2500m) during exercise

    The right heart function (fac, D-Shaping, etc.) will be assessed by echocardiography (TTE) under exercise

    Time frame: 1 day at altitude

07

Study locations

1 site
  • Respiratory Clinic, University Hospital of Zurich
    Zurich, 8091, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03637179
Lead sponsor
University of Zurich
Responsible party
Sponsor
First posted
Aug 17, 2018
Start date
Jul 1, 2018
Primary completion
Jan 1, 2019
Completion
Jan 1, 2019
Last update
Jan 7, 2020

Study contacts

Silvia Ulrich, Prof.
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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