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 CapacityPulmonary 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
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