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

This study is currently recruiting participants.

Verified by University of Heidelberg, November 2007

First Received: November 15, 2007 No Changes Posted

Sponsor:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00559442

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:	Basic Science, Open Label, Uncontrolled, Single Group Assignment
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:

MedlinePlus related topics: Edema Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Study Completion Date:	August 2008

Arms	Assigned Interventions
1: Experimental 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

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

Contacts

Contact: Christoph Dehnert, MD	+49 (0)6221 56-38101	christoph.dehnert@med.uni-heidelberg.de
Contact: Peter Bärtsch, MD, PhD	+49 (0)6221 56-8100	peter.bartsch@med.uni-heidelberg.de

Locations

Germany
Sports Medicine, University Hospital	Recruiting
Heidelberg, Germany, 69120
Contact: Christoph Dehnert, MD +49 (0)6221 / 56 38101 christoph.dehnert@med.uni-heidelberg.de

Sponsors and Collaborators

University of Heidelberg

Investigators

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

More Information

No publications provided

Study ID Numbers:	S-169/2007
Study First Received:	November 15, 2007
Last Updated:	November 15, 2007
ClinicalTrials.gov Identifier:	NCT00559442 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

high altitude pulmonary edema
hypoxic pulmonary vasoconstriction
right ventricular function
hypoxia

Additional relevant MeSH terms:

Altitude Sickness
Signs and Symptoms
Disease Attributes
Pathologic Processes
Pulmonary Edema
Respiratory Tract Diseases

Disease Susceptibility
Lung Diseases
Respiration Disorders
Edema
Genetic Predisposition to Disease

ClinicalTrials.gov processed this record on February 08, 2010