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

High Altitude Pulmonary Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559442
• Other study ID #: S-169/2007
• Status: Completed
• Phase: N/A
• First received: November 15, 2007
• Last updated: September 5, 2013
• Start date: June 2007
• Est. completion date: July 2011

Study information

• Verified date: November 2007
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Altitude Sickness
• Disease Susceptibility
• Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Intervention

Other:
• Altitude Exposure:
rapid ascent to Margherita Hut (4559 m) within 24 h

Locations

Country	Name	City	State
Germany	Sports Medicine, University Hospital	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of HAPE after rapid ascent to 4559 m		during the 48 h stay at altitude	Yes
Secondary	Time course of pulmonary artery pressure		during the 48 h stay at altitude	Yes
Secondary	Assessment of right ventricular function by echocardiography		during the 48 h stay at altitude	Yes