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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

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

NCT ID

NCT02730156

First Posted

March 31, 2016

Last Updated

January 15, 2019

Sponsor

University of Zurich

Collaborators

University of Calgary

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

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

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

Learn more about this trial

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

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