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Effect of Bosentan on Exercise Capacity at High Altitude

NCT ID: NCT00432978

Last Updated: 2007-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-02-28

Brief Summary

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This study is to determine whether bosentan will alter exercise capacity after rapid ascent to high altitude.

We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity.

Detailed Description

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Both the prostacyclin and the nitric oxide pathways are important in modulating hypoxic pulmonary vasoconstriction (HPV). There is little information about the role of the endothelin pathway at high altitude. The endothelin pathway involves the activation of two distinct receptors, A and B. Bosentan is a nonpeptide, specific, competitive, dual antagonist of both endothelin receptor subtypes. The primary objective of this study will be to determine the effect of endothelin receptor blockade with bosentan on exercise performance and HPV. This is a prospective, double blind, placebo-controlled, randomized cross-over study involving healthy subjects aged 25-55 years of age. Subjects will undergo echocardiography and exercise testing at low altitude (\< 500m) and at 3800m. Subjects will receive either bosentan vs. placebo and will be studied at low and high altitude on two occasions in a crossover design. Primary outcome measures will be pulmonary artery systolic pressure measured by echo-Doppler and exercise capacity. A better understanding of the role of the endothelin pathway in HPV may lead to improved treatments for some patients.

Conditions

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Altitude Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Bosentan administration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal healthy subjects aged 18 - 55 years

Exclusion Criteria

* Pregnancy
* Heart, lung or liver disease
* Use of glyburide, cyclosporin A
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Actelion

INDUSTRY

Sponsor Role collaborator

VA Loma Linda Health Care System

FED

Sponsor Role lead

Principal Investigators

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James D Anholm, MD

Role: PRINCIPAL_INVESTIGATOR

VA Loma Linda Healthcare System

Katja Ruh, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

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VA Loma Linda Healthcare System

Loma Linda, California, United States

Site Status

Countries

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United States

References

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Seheult RD, Ruh K, Foster GP, Anholm JD. Prophylactic bosentan does not improve exercise capacity or lower pulmonary artery systolic pressure at high altitude. Respir Physiol Neurobiol. 2009 Feb 28;165(2-3):123-30. doi: 10.1016/j.resp.2008.10.005. Epub 2008 Oct 11.

Reference Type DERIVED
PMID: 18977464 (View on PubMed)

Other Identifiers

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Prom: 0030

Identifier Type: -

Identifier Source: secondary_id

00534

Identifier Type: -

Identifier Source: org_study_id