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Effect of Bosentan on Exercise Capacity at High Altitude

Information source: VA Loma Linda Health Care System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Altitude; Pulmonary Hypertension

Intervention: Bosentan administration (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: VA Loma Linda Health Care System

Official(s) and/or principal investigator(s):
James D Anholm, MD, Principal Investigator, Affiliation: VA Loma Linda Healthcare System
Katja Ruh, MD, Principal Investigator, Affiliation: Loma Linda University

Summary

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.

Clinical Details

Official title: Effect of Bosentan on Exercise Capacity at High Altitude

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Exercise Capacity

Pulmonary artery systolic pressure

Secondary outcome: Hemoglobin oxygen saturation

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Normal healthy subjects aged 18 - 55 years

Exclusion Criteria:

- Pregnancy

- Heart, lung or liver disease

- Use of glyburide, cyclosporin A

Locations and Contacts

VA Loma Linda Healthcare System, Loma Linda, California 92357, United States
Additional Information

Starting date: July 2006
Last updated: April 17, 2007

Page last updated: August 23, 2015

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