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

Primary Purpose

High Altitude Pulmonary Edema

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Altitude Exposure:

About this trial

This is an interventional basic science trial for High Altitude Pulmonary Edema focused on measuring high altitude pulmonary edema, hypoxic pulmonary vasoconstriction, right ventricular function, hypoxia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Sports Medicine, University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

high altitude exposure without prior acclimatization

Outcomes

Primary Outcome Measures

Frequency of HAPE after rapid ascent to 4559 m

Secondary Outcome Measures

Time course of pulmonary artery pressure

Assessment of right ventricular function by echocardiography

Full Information

NCT ID

NCT00559442

First Posted

November 15, 2007

Last Updated

September 5, 2013

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00559442

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Altitude Pulmonary Edema

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

high altitude exposure without prior acclimatization

Intervention Type

Other

Intervention Name(s)

Altitude Exposure:

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of HAPE after rapid ascent to 4559 m

Time Frame

during the 48 h stay at altitude

Secondary Outcome Measure Information:

Title

Time course of pulmonary artery pressure

Time Frame

during the 48 h stay at altitude

Title

Assessment of right ventricular function by echocardiography

Time Frame

during the 48 h stay at altitude

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christoph Dehnert, MD

Organizational Affiliation

University Hospital Heidelberg

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ekkehard Grünig, MD

Organizational Affiliation

University Hospital Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sports Medicine, University Hospital

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

25803140

Citation

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.

Results Reference

derived

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

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