Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00260819
Status:
COMPLETED
Last Update Posted:
2008-10-17
First Post:
2005-12-01
Brief Title:
Effects of Bosentan Tracleer in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Effects of Bosentan Tracleer in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
Status:
COMPLETED
Status Verified Date:
2007-03
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:
Excessive rise in pulmonary artery pressure induced by low oxygen tension hypoxia is one of the factors implicated in high-altitude pulmonary oedema Plasma ET1 increases in subjects exposed to high altitude and is correlated to pulmonary artery pressure
The aim of the study is to investigate whether blockade of ET1 receptors would reduce the acute rise in systolic pulmonary artery pressure induced by hypoxia
The aim of the study is to investigate whether blockade of ET1 receptors would reduce the acute rise in systolic pulmonary artery pressure induced by hypoxia
Detailed Description:
Patients will be examined on a variable load supine bicycle ergometer The exercise table will be tilted laterally by 20 to 30 degrees to the left PASP will be assessed using Doppler echocardiography at rest and during during supine bicycle exercise in NORMOXIA and hypoxia Exposure to normobaric hypoxia will be performed by breathing a hypoxic gas mixture at sea level during 90 minutes 123 O2 877 N2 reproducing conditions at 4300 m altitude Exercise will be started at an initial workload of 40 watts and increased by 10 watts every minute to reach a workload level defined by a heart rate HR corresponding to 50 of the estimated maximal aerobic power
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 |
|---|---|---|---|
| AOR05038 | None | None | None |