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

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00559442
First received: November 15, 2007
Last updated: September 5, 2013
Last verified: November 2007
  Purpose

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).


Condition Intervention
High Altitude Pulmonary Edema
Other: Altitude Exposure:

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Pulmonary Artery Pressure During Exercise in Normoxia and at Rest in Hypoxia

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Frequency of HAPE after rapid ascent to 4559 m [ Time Frame: during the 48 h stay at altitude ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time course of pulmonary artery pressure [ Time Frame: during the 48 h stay at altitude ] [ Designated as safety issue: Yes ]
  • Assessment of right ventricular function by echocardiography [ Time Frame: during the 48 h stay at altitude ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2007
Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
high altitude exposure without prior acclimatization
Other: Altitude Exposure:
rapid ascent to Margherita Hut (4559 m) within 24 h

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00559442

Locations
Germany
Sports Medicine, University Hospital
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Christoph Dehnert, MD University Hospital Heidelberg
Principal Investigator: Ekkehard Grünig, MD University Hospital Heidelberg
  More Information

No publications provided

Responsible Party: Internal Medicine VII, Sports Medicine, Medical Clinic, University Hospital of Heidelberg
ClinicalTrials.gov Identifier: NCT00559442     History of Changes
Other Study ID Numbers: S-169/2007
Study First Received: November 15, 2007
Last Updated: September 5, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
high altitude pulmonary edema
hypoxic pulmonary vasoconstriction
right ventricular function
hypoxia

Additional relevant MeSH terms:
Altitude Sickness
Edema
Disease Susceptibility
Pulmonary Edema
Hypertension, Pulmonary
Signs and Symptoms
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases

ClinicalTrials.gov processed this record on September 18, 2014