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

Not Applicable

Completed

• Conditions: Effect of High Altitude
• Interventions: Other: Altitude exposure

• Registration Number: NCT02730156
• Lead Sponsor: University of Zurich

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Study Start: 2016-04-09
• Primary Completion: 2016-05-04
• Study Completion: 2016-05-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Altitude exposure	Altitude exposure	Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude

Primary Outcome Measures

Name	Time	Method
Systolic pulmonary artery pressure measured by echocardiography	[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 Outcome Measures

Name	Time	Method
Indices of right ventricular dysfunction	[Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; sec

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland