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

NCT00559442 | Completed

• 1 other identifier: S-169/2007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

High Altitude Pulmonary Edema

Keywords

high altitude pulmonary edema; hypoxic pulmonary vasoconstriction; right ventricular function; hypoxia

Outcome Measures

Primary Outcomes (1)

• Frequency of HAPE after rapid ascent to 4559 m

  during the 48 h stay at altitude

Secondary Outcomes (2)

• Time course of pulmonary artery pressure

  during the 48 h stay at altitude

• Assessment of right ventricular function by echocardiography

  during the 48 h stay at altitude

Study Arms (1)

1

EXPERIMENTAL

high altitude exposure without prior acclimatization

Other: Altitude Exposure:

Interventions

Altitude Exposure: OTHER

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

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• abnormal increase of pulmonary artery pressure at rest in hypoxia and during exercise in normoxia
• ability to climb Margherita Hut

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Sports Medicine, University Hospital

Heidelberg, 69120, Germany

Location

Related Publications (1)

• Dehnert C, Mereles D, Greiner S, Albers D, Scheurlen F, Zugel S, Bohm T, Vock P, Maggiorini M, Grunig E, Bartsch 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.

  PMID: 25803140 DERIVED

MeSH Terms

Conditions

Altitude Sickness; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christoph Dehnert, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

• Ekkehard Grünig, MD

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: July 1, 2011
• Last Updated: September 6, 2013

Record last verified: 2007-11

Locations

DE (1)