跳至主要内容
临床试验/NCT00432978
NCT00432978已完成1 期

Effect of Bosentan on Exercise Capacity at High Altitude

VA Loma Linda Health Care System2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2006年7月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Exercise Capacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Normal healthy subjects aged 18 - 55 years

排除标准

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

结局指标

主要结局

Exercise Capacity

Pulmonary artery systolic pressure

次要结局

  • Hemoglobin oxygen saturation

研究者

发起方
VA Loma Linda Health Care System
申办方类型
Fed

研究点 (2)

Loading locations...

相似试验