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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00559442
First Posted: November 16, 2007
Last Update Posted: September 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
November 15, 2007
November 16, 2007
September 6, 2013
June 2007
December 2010   (Final data collection date for primary outcome measure)
Frequency of HAPE after rapid ascent to 4559 m [ Time Frame: during the 48 h stay at altitude ]
Same as current
Complete list of historical versions of study NCT00559442 on ClinicalTrials.gov Archive Site
  • Time course of pulmonary artery pressure [ Time Frame: during the 48 h stay at altitude ]
  • Assessment of right ventricular function by echocardiography [ Time Frame: during the 48 h stay at altitude ]
Same as current
Not Provided
Not Provided
 
Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction
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).
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
High Altitude Pulmonary Edema
Other: Altitude Exposure:
rapid ascent to Margherita Hut (4559 m) within 24 h
Experimental: 1
high altitude exposure without prior acclimatization
Intervention: Other: Altitude Exposure:
Dehnert C, Mereles D, Greiner S, Albers D, Scheurlen F, Zügel S, Böhm T, Vock P, Maggiorini M, Grünig E, Bärtsch 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00559442
S-169/2007
No
Not Provided
Not Provided
Internal Medicine VII, Sports Medicine, Medical Clinic, University Hospital of Heidelberg
Heidelberg University
Not Provided
Principal Investigator: Christoph Dehnert, MD University Hospital Heidelberg
Principal Investigator: Ekkehard Grünig, MD University Hospital Heidelberg
Heidelberg University
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP