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

Study Overview

• Status: Completed
• Conditions: Effect of High Altitude
• Intervention / Treatment: Other: Altitude exposure

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • University of Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Altitude exposure; Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude	Other: Altitude exposure; Altitude exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2016
• Primary Completion (Actual): May 4, 2016
• Study Completion (Actual): May 4, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness
• Other Study ID Numbers: REB15-2709_V2