AltitudePhase 1NCT00432978
Effect of Bosentan on Exercise Capacity at High Altitude
A Phase 1 study testing Bosentan administration in people with Altitude and Pulmonary Hypertension, run by VA Loma Linda Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Altitude, Pulmonary Hypertension
- What is being tested?
- Bosentan administration
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy subjects aged 18 - 55 years
Who cannot join
- Pregnancy
- Heart, lung or liver disease
- Use of glyburide, cyclosporin A
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Loma Linda Healthcare System
Loma Linda, California, 92357
About this study
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.
Read the 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.
- Conditions
- Altitude, Pulmonary Hypertension
- Being tested
- Bosentan administration
- Keywords
- hypoxia, endothelin, exercise
- Medical subject headings
- Hypertension, Pulmonary, Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bosentan administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Capacity
Pulmonary artery systolic pressure
Secondary outcomes (1)
Hemoglobin oxygen saturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2007 (estimated)
- Study startJul 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AltitudeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- VA Loma Linda Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Actelion
- Investigators
- James D Anholm, MD, Principal investigator, VA Loma Linda Healthcare SystemKatja Ruh, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432978
- Sponsor's protocol ID
- 00534
- Other IDs
- Prom: 0030
- Status last verified
- Apr 2007
- First submitted
- 6 Feb 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Seheult RD, Ruh K, Foster GP, Anholm JD. Prophylactic bosentan does not improve exercise capacity or lower pulmonary artery systolic pressure at high altitude. Respir Physiol Neurobiol. 2009 Feb 28;165(2-3):123-30. doi: 10.1016/j.resp.2008.10.005. Epub 2008 Oct 11.
PubMed 18977464
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bosentan on Exercise Capacity at High Altitude
- ClinicalTrials.gov ID
- NCT00432978
- Acronym / sponsor ID
- 00534
- Conditions
- Altitude, Pulmonary Hypertension
- Keywords
- hypoxia, endothelin, exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- VA Loma Linda Health Care SystemUS federal agency
- Collaborators
- Actelion
- Study start
- Jul 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 8 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Normal healthy subjects aged 18 - 55 years
Key exclusion criteria (3 listed)
- Pregnancy
- Heart, lung or liver disease
- Use of glyburide, cyclosporin A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bosentan administration | Drug | – |
Primary outcome
Exercise Capacity
Pulmonary artery systolic pressure
1 secondary outcome
Hemoglobin oxygen saturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2007.
- Derived from this study: PubMed 18977464Seheult RD, Ruh K, Foster GP, Anholm JD. Prophylactic bosentan does not improve exercise capacity or lower pulmonary artery systolic pressure at high altitude. Respir Physiol Neurobiol. 2009 Feb 28;165(2-3):123-30. doi: 10.1016/j.resp.2008.10.005. Epub 2008 Oct 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Anholm, MD principal investigator
VA Loma Linda Healthcare System
Katja Ruh, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bosentan administration in people with Altitude and Pulmonary Hypertension, run by VA Loma Linda Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Capacity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2007.