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

September 5, 2013 updated by: Heidelberg University

Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Pulmonary Artery Pressure During Exercise in Normoxia and at Rest in Hypoxia

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Sports Medicine, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
high altitude exposure without prior acclimatization
Other: Altitude Exposure:
rapid ascent to Margherita Hut (4559 m) within 24 h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of HAPE after rapid ascent to 4559 m
Time Frame: during the 48 h stay at altitude
during the 48 h stay at altitude

Secondary Outcome Measures

Outcome Measure
Time Frame
Time course of pulmonary artery pressure
Time Frame: during the 48 h stay at altitude
during the 48 h stay at altitude
Assessment of right ventricular function by echocardiography
Time Frame: during the 48 h stay at altitude
during the 48 h stay at altitude

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Christoph Dehnert, MD, University Hospital Heidelberg
  • Principal Investigator: Ekkehard Grünig, MD, University Hospital Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-169/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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