Susceptibility to High Altitude Pulmonary Edema in Subjec... | NCT00559442

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

NCT00559442

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Sep 6, 2013Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

High Altitude Pulmonary Edema

Interventions

Altitude Exposure:

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Jul 2011Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 5, 2013

Last Update Posted Date

Sep 6, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	high altitude exposure without prior acclimatization	Other: Altitude Exposure:

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Altitude Exposure:	Other	rapid ascent to Margherita Hut (4559 m) within 24 h	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of HAPE after rapid ascent to 4559 m		during the 48 h stay at altitude

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Dehnert, MD	University Hospital Heidelberg	Principal Investigator
Ekkehard Grünig, MD	University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sports Medicine, University Hospital		Heidelberg		69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25803140	Derived	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.

ID	Term
D000532	Altitude Sickness
D000860	Hypoxia

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms