- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00724321
Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude
September 17, 2015 updated by: Loma Linda University
Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction With Exercise at High Altitude
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 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 Type
Interventional
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, 92354
- Loma Linda University
-
-
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18 - 80 years
- Healthy physically active males or females
- Have readily measurable tricuspid regurgitation (TR) peak systolic velocity by continuous wave Doppler ultrasound
Exclusion Criteria:
- Known liver disease
- Pregnancy
- 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
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Iloprost and placebo
Each participant will undergo testing at sea level and altitude after inhalation of iloprost and placebo, sequence is randomly assigned.
|
A dose of inhaled iloprost (or placebo) will be given once at baseline and then at altitude.
Measurements will be obtained before and after inhalation.
Patients will then cross over and be given a dose of placebo (or iloprost)and measurements will be repeated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate, tissue Doppler echocardiographic measurements
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katja Ruh, MD, Loma Linda University
- Principal Investigator: James Anholm, MD, Loma Linda University
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, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
November 1, 2008
Study Registration Dates
First Submitted
July 25, 2008
First Submitted That Met QC Criteria
July 28, 2008
First Posted (Estimate)
July 29, 2008
Study Record Updates
Last Update Posted (Estimate)
September 18, 2015
Last Update Submitted That Met QC Criteria
September 17, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 58205
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 Hypoxic Pulmonary Vasoconstriction
-
VA Loma Linda Health Care SystemActelionUnknownHypoxic Pulmonary VasoconstrictionUnited States
-
Fudan UniversityCompletedInflammation | Blood Pressure | Oxidative Stress | Pulmonary Function | Vasoconstriction | CoagulationChina
-
University of AlbertaRecruitingVasodilation | VasoconstrictionCanada
-
University of AlbertaCompletedVasodilation | VasoconstrictionCanada
-
University of AlbertaCompletedVasodilation | VasoconstrictionCanada
-
Colorado State UniversityWithdrawnVasodilation | VasoconstrictionUnited States
-
MC2 TherapeuticsCompleted
-
Global Blood TherapeuticsMayo ClinicTerminatedCardio-pulmonary FunctionUnited States
-
University of Texas Southwestern Medical CenterNational Institute on Drug Abuse (NIDA)WithdrawnCocaine Induced Sympathoexciation and VasoconstrictionUnited States
-
University of EdinburghEncysive PharmaceuticalsCompletedPulmonary Arterial Hypertension | Vasodilation | VasoconstrictionUnited Kingdom
Clinical Trials on iloprost
-
University of OklahomaCompletedChronic Obstructive Pulmonary Disease | Pulmonary HypertensionUnited States
-
Charite University, Berlin, GermanySchering-PloughTerminatedSystemic SclerosisGermany
-
ActelionTerminatedPulmonary Arterial HypertensionUnited States
-
ActelionTerminatedPulmonary HypertensionUnited States
-
National Center for Research Resources (NCRR)University of PittsburghCompletedSystemic Sclerosis | Raynaud Disease
-
Lund University HospitalBayerWithdrawnRespiratory Distress Syndrome | Persistent Pulmonary HypertensionSweden
-
University of Colorado, DenverNational Cancer Institute (NCI)CompletedLung Cancer | Precancerous ConditionUnited States
-
BayerCompletedHypertension, PulmonaryItaly, Spain, France, Germany, Portugal, United Kingdom
-
University of ChicagoTerminatedPulmonary HypertensionIsrael, United States
-
BayerCompletedPulmonary HypertensionKorea, Republic of