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Hypoxia |
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Clinical Trial: Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
This study is not yet open for patient recruitment.
Verified by Assistance Publique - Hôpitaux de Paris November 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hypoxia-Induced Pulmonary Artery Hypertension | Drug: Bosentan | Phase I |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Secondary Outcomes: To compare; - pulmonary artery pressure response to exercise,; - exercise capacity,; - oxygen desaturation,; and to assess the global safety
Expected Total Enrollment: 20
Study start: January 2006; Expected completion: March 2007
Last follow-up: December 2006; Data entry closure: January 2007
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- 20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent.
Exclusion Criteria:
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Location and Contact Information
France
Centre d''''Investigation Clinique 9201 Hôpital Européen Georges Pompidou, Paris, 75908 cedex 15, France
Michel AZIZI, MD,PhD, Principal Investigator
Michel AZIZI, MD,PhD, Principal Investigator, Assistance Publique - Hôpitaux de Paris
More Information
Publications that report results of this study
Grunig E, Mereles D, Hildebrandt W, Swenson ER, Kubler W, Kuecherer H, Bartsch P. Stress Doppler echocardiography for identification of susceptibility to high altitude pulmonary edema. J Am Coll Cardiol. 2000 Mar 15;35(4):980-7.
Last Updated: December 8, 2005
Record first received: December 1, 2005
ClinicalTrials.gov Identifier: NCT00260819
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Anoxia (National Institute of Neurological Disorders and Stroke)
- Cerebral Hypoxia (Cleveland Clinic)
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