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Completed

NCT Number: NCT02730156

Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders

Prospective interventional trial in lowlanders evaluating effect of acute exposure, acclimatization and re-exposure to high altitude

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Key information

Conditions

Effect of High Altitude

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zurich

Zurich, 8091, Switzerland

About this study

Low altitude baseline measurements will be performed in Santiago de Chile, 520 m, over the course of 3 days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride) to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile. Participants will stay there for the next 7 nights and they will be spend the days (6-8 h daily) at the telescope station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050 m will be by car (1 h ride, one way). After the first 7 day altitude sojourn participants will return to the Santiago area (520 m) for a 7 day recovery period.

A second altitude sojourn cycle with an identical schedule as the one described above and a final low altitude stay of 3 days will follow.

Measurements on study subjects will be performed at baseline (lowland, Santiago de Chile), then at 2nd day of altitude exposure and 7th day at altitude before returning to lowland; those are repeated in the second altitude sojourn cycle. Measurements will be conducted by qualified specialists using a portable ultrasound device.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Born, raised and currently living <800m
  • No overnight stay at altitudes >1500 m 4 weeks before the study

Exclusion criteria

  • Previous altitude intolerance to altitude <3000 m
  • Pregnancy
  • Health impairment, which requires regular treatment

Treatment and study plan

Altitude exposure

Other

Altitude exposure

Primary outcomes

  1. Systolic pulmonary artery pressure measured by echocardiography

    Time frame: [Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2, 7]

    Change in systolic pulmonary artery pressure over the course of high altitude exposure during 2 sojourns at 5050 m

Secondary outcomes

  1. Indices of right ventricular dysfunction

    Time frame: [Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; sec

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • University of Calgary

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Jan 17, 2019

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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