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OpenTrials
Completed

NCT Number: NCT00559442

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

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).

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Medicine, University Hospital

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Altitude Exposure:

Other

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

Primary outcomes

  1. Frequency of HAPE after rapid ascent to 4559 m

    Time frame: during the 48 h stay at altitude

Secondary outcomes

  1. Time course of pulmonary artery pressure

    Time frame: during the 48 h stay at altitude

  2. Assessment of right ventricular function by echocardiography

    Time frame: during the 48 h stay at altitude

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Nov 16, 2007
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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