Inflammatory Profiling in Chronic Lung Disease
1 other identifier
observational
60
1 country
1
Brief Summary
The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2020
CompletedFirst Posted
Study publicly available on registry
December 4, 2020
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedApril 16, 2024
April 1, 2024
3.1 years
November 25, 2020
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Analysis of inflammatory cell profile
The number of leukocytes (CD45+ cells) and derivatives (percentage lymphocytes, monocytes and neutrophils) will be measured by flow cytometry in explanted lung tissue and blood of patients with CLD-PH and controls. Values will be reported as %CD45+ and %total cells.
within 36 months
Secondary Outcomes (1)
Degree of pulmonary vascular disease
within 36 months
Study Arms (3)
COPD-PH group
Patients with confirmed COPD and pulmonary hypertension
IPF-PH
Patients with confirmed pulmonary fibrosis and pulmonary hypertension
Control group
Control group without diagnosed COPD, IPF, or pulmonary hypertension
Interventions
Blood collection via venipuncture into citrate- or ethylenediaminetetraacetic (EDTA)-containing vacutainer tubes and into serum tubes. Explant lung tissue obtained from patients that underwent lung transplantation. Non-transplanted donor lungs that had been harvested for transplantation, but not implanted because of size-reduction serve as controls.
Eligibility Criteria
Subjects undergoing lung transplantation at the Medical University of Vienna
You may qualify if:
- Patients undergoing lung transplant with COPD or IPF, with associated PH
- Signed informed consent
You may not qualify if:
- patients without written informed consent
- Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig Boltzmann Institute for Lung Vascular Researchlead
- Medical University of Grazcollaborator
- Medical University of Viennacollaborator
Study Sites (1)
Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna
Vienna, 1090, Austria
Biospecimen
Blood samples, explant lung tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leigh Marsh
Ludwig Boltzmann Institute for Lung Vascular Research
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2020
First Posted
December 4, 2020
Study Start
December 1, 2021
Primary Completion
December 30, 2024
Study Completion
June 30, 2025
Last Updated
April 16, 2024
Record last verified: 2024-04