Prevention of High Altitude Pulmonary Edema

High Altitude Pulmonary Edema Clinical Trial

Official title:

A Randomized Controlled Trial of the Effects of Tadalafil and Dexamethasone Versus Placebo on Pulmonary Edema Formation and Cerebral Blood Flow Autoregulation in High Altitude Newcomers With a Previous History of High Altitude Pulmonary Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274430
• Other study ID #: margherita03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 9, 2006
• Last updated: November 30, 2006
• Start date: July 2003
• Est. completion date: September 2003

Study information

• Verified date: December 2003
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

A double-blind placebo controlled study

• To compare the effect of tadalafil and dexamethasone versus placebo on Ppa and pulmonary edema formation in subjects susceptible to HAPE.

• To investigate the effect of dexamethasone on alveolar fluid clearance, as assessed by measurement of the nasal potential difference, and prevention of HAPE.

• To investigate the effect of the tadalafil and dexamethasone versus placebo on the dynamic CBF autoregulation properties and on the development of AMS in HAPE susceptible subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• At least one previous episode of high altitude pulmonary edema

Exclusion Criteria:

• pulmonary arterial hypertension

• congenital heart disease

• any chronic lung disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Altitude Sickness
• Edema
• High Altitude Pulmonary Edema
• Hypertension, Pulmonary
• Pulmonary Edema

Intervention

Drug:
• dexamethasone 8 mg bid

• tadalafil 10mg bid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

References & Publications (1)

Maggiorini M, Brunner-La Rocca HP, Peth S, Fischler M, Böhm T, Bernheim A, Kiencke S, Bloch KE, Dehnert C, Naeije R, Lehmann T, Bärtsch P, Mairbäurl H. Both tadalafil and dexamethasone may reduce the incidence of high-altitude pulmonary edema: a randomize — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevention of high altitude pulmonary edema
Secondary	incidence of acute mountain sickness