- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00432978
Effect of Bosentan on Exercise Capacity at High Altitude
April 17, 2007 updated by: VA Loma Linda Health Care System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Loma Linda, California, United States, 92357
- VA Loma Linda Healthcare System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Normal healthy subjects aged 18 - 55 years
Exclusion Criteria:
- Pregnancy
- Heart, lung or liver disease
- Use of glyburide, cyclosporin A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Exercise Capacity
|
Pulmonary artery systolic pressure
|
Secondary Outcome Measures
Outcome Measure |
---|
Hemoglobin oxygen saturation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katja Ruh, MD, Loma Linda University
- Principal Investigator: James D Anholm, MD, VA Loma Linda Healthcare System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
February 6, 2007
First Submitted That Met QC Criteria
February 6, 2007
First Posted (Estimate)
February 8, 2007
Study Record Updates
Last Update Posted (Estimate)
April 18, 2007
Last Update Submitted That Met QC Criteria
April 17, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00534
- Prom: 0030
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pulmonary Hypertension
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
BayerCompletedPrimary HypertensionChina
-
Heidelberg UniversityMerck Sharp & Dohme LLCRecruitingChronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial HypertensionGermany
-
University of South FloridaWithdrawnPulmonary Arterial Hypertension | Familial Primary Pulmonary Hypertension | Idiopathic Pulmonary Arterial Hypertension | Primary Pulmonary HypertensionUnited States
-
Papworth Hospital NHS Foundation TrustMerck Sharp & Dohme LLCCompleted
-
Vanderbilt University Medical CenterJohns Hopkins UniversityCompletedPulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Associated Pulmonary Arterial Hypertension | Heritable Pulmonary Arterial HypertensionUnited States
-
University of Kansas Medical CenterRecruitingPulmonary Arterial Hypertension | Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Hypertension Due to Left Heart Disease | Pulmonary Hypertension, Primary, 4 | Pulmonary Hypertension, Primary, 2 | Pulmonary Hypertension, Primary, 3 | Pulmonary Hypertension, Primary and other conditionsUnited States
-
University of ZurichCompletedPulmonary Hypertension | Pulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary HypertensionSwitzerland
-
University of ZurichActive, not recruitingPulmonary Artery Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Vascular DisorderSwitzerland
Clinical Trials on Bosentan administration
-
Competence Network for Congenital Heart DefectsGerman Federal Ministry of Education and Research; ActelionCompleted
-
Universitair Ziekenhuis BrusselCompleted
-
ActelionCompletedDigital UlcersFrance, United Kingdom, United States, Austria, Canada, Germany, Italy, Switzerland
-
GeropharmCompletedBioequivalenceRussian Federation
-
ActelionCompletedSystemic Sclerosis | Digital UlcersUnited States, Canada
-
ActelionCompletedPulmonary HypertensionUnited States, Canada, Australia, Germany, Italy, United Kingdom, France, Austria, Belgium, Czech Republic, Netherlands, Poland, Spain
-
Medical University of ViennaCompletedGlaucoma | Blood Flow VelocityAustria
-
ActelionCompletedPulmonary Arterial Hypertension Related to Eisenmenger PhysiologyCanada, United Kingdom, Italy, United States, Netherlands, Australia, Austria, Belgium, France, Germany, Spain
-
ActelionCompletedInterstitial Lung Disease | SclerodermaUnited States, Korea, Republic of, Israel, France, United Kingdom, Netherlands, Switzerland, Germany, Canada, Italy, Sweden
-
General Hospital of ChalkidaUnknownSECONDARY PULMONARY HYPERTENSION | MITRAL STENOSIS | CHILDHOOD RHEUMATOID FEVER | CONGESTIVE HEART FAILUREGreece