Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432978
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-02-06
Brief Title:
Effect of Bosentan on Exercise Capacity at High Altitude
Sponsor:
VA Loma Linda Health Care System
Organization:
VA Loma Linda Health Care System
Study Overview
Official Title:
Effect of Bosentan on Exercise Capacity at High Altitude
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
We hypothesize that bosentan administration will improve arterial oxygenation and exercise capacity
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Prom 0030 | None | None | None |