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

Effect of High Altitude Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730156
• Other study ID #: REB15-2709_V2
• Status: Completed
• Phase: N/A
• Start date: April 9, 2016
• Est. completion date: May 4, 2016

Study information

• Verified date: January 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 4, 2016
• Est. primary completion date: May 4, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Altitude Sickness
• Effect of High Altitude

Intervention

Other:
• Altitude exposure
Altitude exposure

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	University of Calgary

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic pulmonary artery pressure measured by echocardiography	Change in systolic pulmonary artery pressure over the course of high altitude exposure during 2 sojourns at 5050 m	[Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; second sojourn at 5050 m, day 2, 7]
Secondary	Indices of right ventricular dysfunction		[Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; sec