Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude - Full Text View

Sponsors and Collaborators:	VA Loma Linda Health Care System Actelion
Information provided by:	VA Loma Linda Health Care System
ClinicalTrials.gov Identifier:	NCT00708565

Purpose

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.

Condition	Intervention	Phase
Hypoxic Pulmonary Vasoconstriction	Drug: iloprost	Phase I

MedlinePlus related topics: Exercise and Physical Fitness

Drug Information available for: Iloprost BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude

Further study details as provided by VA Loma Linda Health Care System:

Primary Outcome Measures:

Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Heart rate, tissue Doppler echocardiographic measurements [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708565

Locations

United States, California
Jerry L. Pettis VA Medical Center	Recruiting
Loma Linda, California, United States, 92357
Contact: James D Anholm, MD 909-583-6098 James.Anholm@va.gov

Sponsors and Collaborators

VA Loma Linda Health Care System

Actelion

Investigators

Principal Investigator:

James D Anholm, MD

Jerry L. Pettis VA Mecial Center

More Information

Responsible Party:	VA Loma Linda Healthcare System ( James D Anholm, MD )
Study ID Numbers:	00769
Study First Received:	June 30, 2008
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00708565
Health Authority:	United States: Federal Government

Keywords provided by VA Loma Linda Health Care System:

To study the effects of iloprost on hypoxic pulmonary vasoconstriction at high altitude

Study placed in the following topic categories:

Iloprost

Additional relevant MeSH terms:

Vasodilator Agents
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009