Characterization of Apolipoprotein A-I Pathways in Idiopathic Pulmonary Fibrosis

  • STATUS
    Not Recruiting
  • End date
    Dec 31, 2029
  • participants needed
    500
  • sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
Updated on 23 May 2022
ct scan
chest x-ray
x-rays
chest ct
pulmonary disease
idiopathic pulmonary fibrosis
walk tests
Accepts healthy volunteers

Summary

Background
  • Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that becomes worse over time. There is currently no effective treatment for it. Researchers want to study the disease and learn new ways to treat it.
    Objectives
  • To discover new pathways that are involved in pulmonary fibrosis. To develop new drugs that may be used to treat pulmonary fibrosis.
    Eligibility
  • People at least 18 years old with IPF.
  • Healthy volunteers at least 18 years old.
    Design
  • Participants will be screened with medical history, questionnaire, and physical exam. They will have blood, lung, and walking tests and chest scans.
  • All participants will have 1 study visit, including:
  • Medical history and physical exam.
  • Questions about their breathing.
  • Blood tests.
  • Breathing tests.
  • Six-minute walk test.
  • Pregnancy test.
  • Chest x-ray (healthy volunteers) or chest CT scan (people with pulmonary fibrosis ).
  • Small area of skin may be removed.
  • Genetic tests of blood and skin samples. Participants will probably not be informed of any findings. Samples may be used to make stem cells for use in research. Participants may be contacted in the future to give consent for this research.
  • Some participants will have repeat visits over many years, repeating many of the study tests.

Description

Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive disease that occurs primarily in older individuals, 55 to 75 years of age, with a median survival of approximately 3 years from time of diagnosis. At present, there are no effective treatments for patients with IPF. Levels of apolipoprotein A-I (apoA-I) have been found to be reduced in the lungs of patients with IPF, while administration of human apoA-I has been shown to reduce bleomycin-induced collagen deposition in a murine model. Here, we would like to assess whether apoA-I pathways modify lung cell biology in patients with IPF. This is a specimen procurement, clinical phenotyping and genotyping protocol that will assess whether holo-apoA-I and apolipoprotein A-I mimetic peptides, can attenuate key pathogenic manifestations of IPF, such as proliferation and extracellular matrix generation by pulmonary fibroblasts, which may serve as evidence to support future human clinical trials of apoA-I for the treatment of IPF. Furthermore, the identification of new apoA-I responsive genes and pathways that mediate fibroblast proliferation in IPF may provide insights into disease pathogenesis and identify new therapeutic targets. Lastly, if induced pluripotent stem (iPS) cells can be successfully shown to model responsiveness of lung cells to apoA-I therapy, then this approach may be expanded with the goal of providing a personalized medicine analysis that could in the future guide selection of the most effective therapy for individual patients.

Details
Condition Idiopathic Pulmonary Fibrosis
Clinical Study IdentifierNCT02315586
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last Modified on23 May 2022

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note