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

Primary Purpose

Effect of High Altitude

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Altitude exposure
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Effect of High Altitude

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Zurich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Altitude exposure

Arm Description

Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Indices of right ventricular dysfunction

Full Information

First Posted
March 31, 2016
Last Updated
January 15, 2019
Sponsor
University of Zurich
Collaborators
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT02730156
Brief Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders
Official Title
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Right Ventricular Function in Lowlanders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 9, 2016 (Actual)
Primary Completion Date
May 4, 2016 (Actual)
Study Completion Date
May 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
University of Calgary

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of High Altitude

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Altitude exposure
Arm Type
Experimental
Arm Description
Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude
Intervention Type
Other
Intervention Name(s)
Altitude exposure
Intervention Description
Altitude exposure
Primary Outcome Measure Information:
Title
Systolic pulmonary artery pressure measured by echocardiography
Description
Change in systolic pulmonary artery pressure over the course of high altitude exposure during 2 sojourns at 5050 m
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]
Secondary Outcome Measure Information:
Title
Indices of right ventricular dysfunction
Time Frame
[Time Frame: lowland baseline at 520m, day 2; first sojourn at 5050 m, day 2, 7; sec

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konrad E Bloch, MD
Organizational Affiliation
University of Zurich
Official's Role
Study Chair
Facility Information:
Facility Name
University of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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

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