Effect of High Altitude Exposure, Acclimatization and Re-... | NCT02730156

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

NCT02730156

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Jan 17, 2019Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Effect of High Altitude

Interventions

Altitude exposure

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 9, 2016Actual

Primary Completion Date

May 4, 2016Actual

Completion Date

May 4, 2016Actual

First Submitted Date

Mar 31, 2016

First Submission Date that Met QC Criteria

Mar 31, 2016

First Posted Date

Apr 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2019

Last Update Posted Date

Jan 17, 2019Actual

Name	Class
University of Calgary	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Altitude exposure	Experimental	Acute high altitude exposure followed by 7 day acclimatization and reexposure after 7 days at low altitude	Other: Altitude exposure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Altitude exposure	Other	Altitude exposure	Altitude exposure

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konrad E Bloch, MD	University of Zurich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Zurich		Zurich		8091	Switzerland