Recruiting
Phase 1

Iloprost

Sponsor:

VA Loma Linda Health Care System

Code:

NCT00708565

Conditions

Hypoxic Pulmonary Vasoconstriction

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

iloprost

Study Details

Brief 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.

Conditions

Hypoxic Pulmonary Vasoconstriction

Study ID

NCT00708565

Start date

Jul, 2008

Status verified date

Jun, 2008

Completion date

Oct, 2008

Anticipated

Primary completion date

Oct, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age: 18 - 80 years
2. Healthy physically active males or females
3. Have readily measurable tricuspid regurgitation (TR) peak systolic velocity by continuous wave Doppler ultrasound

Exclusion Criteria:

1. Unable to measure TR velocity
2. Known liver disease
3. Pregnancy
4. Nitrates, cyclosporin, glyburide or other medications that in the opinion of the investigators could place subjects at increased risk of complications
5. Any other medical condition that in the opinion of the investigators would place the subject at high risk

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Interventions

iloprost

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.

Primary outcome measure

  • Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Jerry L. Pettis VA Medical Center

Recruiting

Loma Linda, California, United States, 92357

Contacts

James D Anholm, MD

909-583-6098James.Anholm@va.gov

More Information

Sponsor

VA Loma Linda Health Care System

Last update posted

Jul 2, 2008

Last verified

Jun, 2008

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Loma Linda Health Care System on 2008-07-02.