Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction and Exercise Capacity at High Altitude

NCT00708565 | Unknown Phase 1

• 1 other identifier: 00769
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Exercise capacity, pulmonary artery systolic pressure, cardiac output, oxygen saturation

  6 months

Secondary Outcomes (1)

• Heart rate, tissue Doppler echocardiographic measurements

  6 months

Interventions

iloprost DRUG

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.

Also known as: Ventavis (brand name)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Loma Linda Health Care System: lead
• Actelion: collaborator

Study Sites (1)

Jerry L. Pettis VA Medical Center

Loma Linda, California, 92357, United States

RECRUITING

MeSH Terms

Interventions

Iloprost

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• James D Anholm, MD

  Jerry L. Pettis VA Mecial Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 2, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: July 2, 2008

Record last verified: 2008-06

Locations

US (1)