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Completed

NCT Number: NCT00432978

Effect of Bosentan on Exercise Capacity at High Altitude

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.

Completed

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Key information

Conditions

Altitude Behavior Cardiovascular Diseases Hypertension Hypertension, Pulmonary Hypoxia Lung Diseases Motor Activity Pathological Conditions, Signs and Symptoms Pulmonary Hypertension Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Loma Linda Healthcare System

Loma Linda, California, 92357, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal healthy subjects aged 18 - 55 years

Exclusion criteria

  • Pregnancy
  • Heart, lung or liver disease
  • Use of glyburide, cyclosporin A

Treatment and study plan

Bosentan administration

Drug

Primary outcomes

  1. Exercise Capacity

  2. Pulmonary artery systolic pressure

Secondary outcomes

  1. Hemoglobin oxygen saturation

Sponsors and collaborators

Lead sponsor

VA Loma Linda Health Care System

Fed

Collaborators

  • Actelion

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Feb 8, 2007
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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