Hypoxic Pulmonary VasoconstrictionPhase 1NCT00708565
Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude
A Phase 1 study testing iloprost in people with Hypoxic Pulmonary Vasoconstriction, run by VA Loma Linda Health Care System at 1 site in United States.
Trial summary
The objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxic Pulmonary Vasoconstriction
- What is being tested?
- iloprost
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Oct 2008
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18 - 80 years
- Healthy physically active males or females
- Have readily measurable tricuspid regurgitation (TR) peak systolic velocity by continuous wave Doppler ultrasound
Who cannot join
- Unable to measure TR velocity
- Known liver disease
- Pregnancy
- Nitrates, cyclosporin, glyburide or other medications that in the opinion of the investigators could place subjects at increased risk of complications
- Any other medical condition that in the opinion of the investigators would place the subject at high risk
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Jerry L. Pettis VA Medical Center
Loma Linda, California, 92357
James D Anholm, MD, 909-583-6098, James.Anholm@va.gov
About this study
The objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude.
Read the detailed description
Three major pathways in addition to oxygen modulate pulmonary vascular tone: 1) nitric oxide, 2) endothelin, and 3) prostacyclin. Considerable animal data support the role of the prostacyclin pathway in modulating hypoxic pulmonary vasoconstriction. In humans, prostacyclin and its analogs are important therapeutic agents in the treatment of pulmonary arterial hypertension (PAH). Despite the animal data and human data in PAH there is very little information about the use of iloprost to relieve hypoxic pulmonary vasoconstriction in healthy humans. Inhaled iloprost is an ideal agent to study the prostacyclin pathway due to its short duration of action (30-90 min) and elimination half-life of only 20-30 min. Individuals already participating in the Nepal Medex 2008 trip will be invited to participate in this research. Participants will be healthy active females or males, between 18-80 years of age, without known pregnancy or liver disease, who have a readily measurable tricuspid regurgitant velocity by Doppler echocardiography. If possible, we will attempt to identify a cohort of HAPE susceptible patients. Participants will undergo evaluation both at sea level (baseline) and at high altitude. Baseline (low altitude) testing will be performed in Bangor, North Wales, UK, and will include evaluation of pulmonary artery systolic pressures, cardiac output, and oxygen saturation at rest and during submaximal exercise before and after inhalation of iloprost. This strategy will then be repeated at an altitude of approximately 5000 meters in the Dhaulagiri region of Nepal.
- Conditions
- Hypoxic Pulmonary Vasoconstriction
- Being tested
- iloprost
- Keywords
- To study the effects of iloprost on hypoxic pulmonary vasoconstriction at high altitude
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloprostDrug
Also called Ventavis (brand name)
Baseline echo measurements, cardiac output, pulse oximetry will be taken. Subjects will then be given one dose of inhaled iloprost. Post-inhalation, the measurements will be repeated at rest and with exercise.
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation
Measured: 6 months
Secondary outcomes (1)
Heart rate, tissue Doppler echocardiographic measurements
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Pulmonary VasoconstrictionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
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, Jerry L. Pettis VA Mecial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00708565
- Sponsor's protocol ID
- 00769
- Status last verified
- Jun 2008
- First submitted
- 30 Jun 2008
- Last updated
- 2 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude
- ClinicalTrials.gov ID
- NCT00708565
- Acronym / sponsor ID
- 00769
- Conditions
- Hypoxic Pulmonary Vasoconstriction
- Keywords
- To study the effects of iloprost on hypoxic pulmonary vasoconstriction at high altitude
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Loma Linda Health Care SystemUS federal agency
- Collaborators
- Actelion
- Study start
- Jul 2008
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 2 Jul 2008 (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.
The objective of this study is to determine if single dose administration of inhaled iloprost will reduce pulmonary artery pressure, reduce hypoxic pulmonary vasoconstriction and improve arterial oxygenation at rest and during exercise at high altitude.
Detailed description
Three major pathways in addition to oxygen modulate pulmonary vascular tone: 1) nitric oxide, 2) endothelin, and 3) prostacyclin. Considerable animal data support the role of the prostacyclin pathway in modulating hypoxic pulmonary vasoconstriction. In humans, prostacyclin and its analogs are important therapeutic agents in the treatment of pulmonary arterial hypertension (PAH). Despite the animal data and human data in PAH there is very little information about the use of iloprost to relieve hypoxic pulmonary vasoconstriction in healthy humans. Inhaled iloprost is an ideal agent to study the prostacyclin pathway due to its short duration of action (30-90 min) and elimination half-life of only 20-30 min. Individuals already participating in the Nepal Medex 2008 trip will be invited to participate in this research. Participants will be healthy active females or males, between 18-80 years of age, without known pregnancy or liver disease, who have a readily measurable tricuspid regurgitant velocity by Doppler echocardiography. If possible, we will attempt to identify a cohort of HAPE susceptible patients. Participants will undergo evaluation both at sea level (baseline) and at high altitude. Baseline (low altitude) testing will be performed in Bangor, North Wales, UK, and will include evaluation of pulmonary artery systolic pressures, cardiac output, and oxygen saturation at rest and during submaximal exercise before and after inhalation of iloprost. This strategy will then be repeated at an altitude of approximately 5000 meters in the Dhaulagiri region of Nepal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18 - 80 years
- Healthy physically active males or females
- Have readily measurable tricuspid regurgitation (TR) peak systolic velocity by continuous wave Doppler ultrasound
Key exclusion criteria (5 listed)
- Unable to measure TR velocity
- Known liver disease
- Pregnancy
- Nitrates, cyclosporin, glyburide or other medications that in the opinion of the investigators could place subjects at increased risk of complications
- Any other medical condition that in the opinion of the investigators would place the subject at high risk
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 |
|---|---|---|
| iloprostAlso: Ventavis (brand name)Baseline echo measurements, cardiac output, pulse oximetry will be taken. Subjects will then be given one dose of inhaled iloprost. Post-inhalation, the measurements will be repeated at rest and with exercise. | Drug | – |
Primary outcome
Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation
Time frame: 6 months
1 secondary outcome
Heart rate, tissue Doppler echocardiographic measurements
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2008.
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
Jerry L. Pettis VA Mecial Center
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 iloprost in people with Hypoxic Pulmonary Vasoconstriction, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Jul 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2008.