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Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction

NCT ID: NCT00559442

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2011-07-31

Brief Summary

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It has been shown, that subjects susceptible to high altitude pulmonary edema (HAPE)are characterized by an abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia. This abnormal rise of pulmonary artery pressure has also been observed in about 10 % of otherwise healthy subjects without prior altitude exposure. The aim of the study is to investigate the susceptibility to HAPE in unacclimatized subjects with abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia after rapid ascent to high altitude (4559 m).

Detailed Description

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Conditions

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High Altitude Pulmonary Edema

Keywords

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high altitude pulmonary edema hypoxic pulmonary vasoconstriction right ventricular function hypoxia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

high altitude exposure without prior acclimatization

Group Type EXPERIMENTAL

Altitude Exposure:

Intervention Type OTHER

rapid ascent to Margherita Hut (4559 m) within 24 h

Interventions

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Altitude Exposure:

rapid ascent to Margherita Hut (4559 m) within 24 h

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia
* ability to climb Margherita Hut

Exclusion Criteria

* Birth at or above 1500 m altitude
* any cardiovascular or pulmonary disease
* Infection disease
* Intake of drugs, in particular Acetazolamide, Nifedipine, corticosteroids or PDE-5-inhibitors.
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Medical Clinic, University Hospital of Heidelberg

Principal Investigators

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Christoph Dehnert, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Ekkehard Grünig, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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Sports Medicine, University Hospital

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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Dehnert C, Mereles D, Greiner S, Albers D, Scheurlen F, Zugel S, Bohm T, Vock P, Maggiorini M, Grunig E, Bartsch P. Exaggerated hypoxic pulmonary vasoconstriction without susceptibility to high altitude pulmonary edema. High Alt Med Biol. 2015 Mar;16(1):11-7. doi: 10.1089/ham.2014.1117.

Reference Type DERIVED
PMID: 25803140 (View on PubMed)

Other Identifiers

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S-169/2007

Identifier Type: -

Identifier Source: org_study_id