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Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude

This study has been withdrawn prior to enrollment.
(PI has left the institution. We are unable to locate any study records to determine if subjects were enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00724321
First Posted: July 29, 2008
Last Update Posted: September 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Loma Linda University
  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: Intervention Model: Single Group Assignment
Masking: Triple (Participant, 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:


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 ]

Secondary Outcome Measures:
  • Heart rate, tissue Doppler echocardiographic measurements [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Iloprost and placebo
Each participant will undergo testing at sea level and altitude after inhalation of iloprost and placebo, sequence is randomly assigned.
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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724321


Locations
United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Katja Ruh, MD Loma Linda University
Principal Investigator: James Anholm, MD Loma Linda University
  More Information

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00724321     History of Changes
Other Study ID Numbers: 58205
First Submitted: July 25, 2008
First Posted: July 29, 2008
Last Update Posted: September 18, 2015
Last Verified: September 2015

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

Additional relevant MeSH terms:
Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents