Effects of Iloprost on Hypoxic Pulmonary Vasoconstriction at Altitude

NCT00724321 | Withdrawn Phase 1

• 1 other identifier: 58205
• Study Type: interventional
• Target: N/A
• 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

iloprost; hypoxic; pulmonary; vasoconstriction; 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

Study Arms (1)

Iloprost and placebo

OTHER

Each participant will undergo testing at sea level and altitude after inhalation of iloprost and placebo, sequence is randomly assigned.

Drug: iloprost

Interventions

iloprost DRUG

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.

Iloprost and placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• 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:

• Known liver disease
• Pregnancy
• 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

• Loma Linda University: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Katja Ruh, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

• James Anholm, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: July 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 18, 2015

Record last verified: 2015-09

Locations

US (1)