Effect of Bosentan on Exercise Capacity at High Altitude

This study has been completed.
Sponsor:
Collaborator:
Actelion
Information provided by:
VA Loma Linda Health Care System
ClinicalTrials.gov Identifier:
NCT00432978
First received: February 6, 2007
Last updated: April 17, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Altitude
Pulmonary Hypertension
Drug: Bosentan administration
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Bosentan on Exercise Capacity at High Altitude

Resource links provided by NLM:


Further study details as provided by VA Loma Linda Health Care System:

Primary Outcome Measures:
  • Exercise Capacity
  • Pulmonary artery systolic pressure

Secondary Outcome Measures:
  • Hemoglobin oxygen saturation

Estimated Enrollment: 20
Study Start Date: July 2006
Study Completion Date: February 2007
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal healthy subjects aged 18 - 55 years

Exclusion Criteria:

  • Pregnancy
  • Heart, lung or liver disease
  • Use of glyburide, cyclosporin A
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00432978

Locations
United States, California
VA Loma Linda Healthcare System
Loma Linda, California, United States, 92357
Sponsors and Collaborators
VA Loma Linda Health Care System
Actelion
Investigators
Principal Investigator: James D Anholm, MD VA Loma Linda Healthcare System
Principal Investigator: Katja Ruh, MD Loma Linda University
  More Information

No publications provided by VA Loma Linda Health Care System

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00432978     History of Changes
Other Study ID Numbers: 00534, Prom: 0030
Study First Received: February 6, 2007
Last Updated: April 17, 2007
Health Authority: United States: Federal Government

Keywords provided by VA Loma Linda Health Care System:
hypoxia
endothelin
exercise

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bosentan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014