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Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Loma Linda University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Actelion
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00724321
First received: July 25, 2008
Last updated: July 28, 2008
Last verified: July 2008
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction With Exercise at High Altitude

Resource links provided by NLM:

Drug Information available for: Iloprost
U.S. FDA Resources

Further study details as provided by Loma Linda University:

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: November 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: iloprost
    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.
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.

  Eligibility

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

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. Known liver disease
  2. Pregnancy
  3. 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: NCT00724321

Contacts
Contact: Katja Ruh, MD 909-583-6098
Contact: James Anholm, MD 909-825-7084 ext 2692 james.anholm@va.gov

Locations
United States, California
Loma Linda University Not yet recruiting
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Actelion
Investigators
Principal Investigator: Katja Ruh, MD Loma Linda University
  More Information

No publications provided

Responsible Party: Dr. Katja Ruh, Loma Linda University Medical Center
ClinicalTrials.gov Identifier: NCT00724321     History of Changes
Other Study ID Numbers: 58205
Study First Received: July 25, 2008
Last Updated: July 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
iloprost
hypoxic
pulmonary
vasoconstriction
altitude

Additional relevant MeSH terms:
Iloprost
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013