Susceptibility to High Altitude Pulmonary Edema in Subjects With Increased Hypoxic Pulmonary Vasoconstriction
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University of Heidelberg.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Heidelberg
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00559442
First received: November 15, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
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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 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 |
|---|---|
|
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
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
| ClinicalTrials.gov Identifier: | NCT00559442 History of Changes |
| Other Study ID Numbers: | S-169/2007 |
| Study First Received: | November 15, 2007 |
| Last Updated: | November 15, 2007 |
| 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:
|
Disease Susceptibility Genetic Predisposition to Disease Edema Pulmonary Edema Altitude Sickness Hypertension, Pulmonary |
Disease Attributes Pathologic Processes Signs and Symptoms Lung Diseases Respiratory Tract Diseases Respiration Disorders |
ClinicalTrials.gov processed this record on May 22, 2013