Inflammatory Profiling in Chronic Lung Disease

The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: Other: Tissue sampling

Detailed Description

Chronic lung diseases (CLD), such as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are often complicated by the presence of pulmonary hypertension (PH), where even a mild elevation of blood pressure in the pulmonary arteries is associated with an even poorer prognosis. In this study, we will investigate whether similarities exist in the inflammatory profile that could potentially underlie all forms of pulmonary hypertension. Inflammatory data will be generated using flow cytometry, expression profiling and histological analysis and compared to the associated clinical data.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Leigh Marsh; Phone Number: +4331638572911; Email: leigh.marsh@lvr.lbg.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna
    • Contact: Walter Klepetko, Prof; Phone Number: 56440 0043140400; Email: walter.klepetko@meduniwien.ac.at
    • Contact: Elisabeth Gschwandtner, Dr; Phone Number: 56440 0043140400; Email: elisabeth.gschwandtner@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects undergoing lung transplantation at the Medical University of Vienna

Description

Inclusion Criteria:

• Patients undergoing lung transplant with COPD or IPF, with associated PH
• Signed informed consent

Exclusion Criteria:

• patients without written informed consent
• Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD-PH group; Patients with confirmed COPD and pulmonary hypertension	Other: Tissue sampling; 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.
IPF-PH; Patients with confirmed pulmonary fibrosis and pulmonary hypertension	Other: Tissue sampling; 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.
Control group; Control group without diagnosed COPD, IPF, or pulmonary hypertension	Other: Tissue sampling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of pulmonary vascular disease	Pulmonary vascular disease will be assessed by associated clinical data (mPAP (mmHg), PVR (WU)); CLD without PH (mPAP <21 mmHg, or mPAP 21-24 mmHg with pulmonary vascular resistance (PVR) <3 Wood Units (WU)).; CLD with PH (mPAP 21-24 mmHg with PVR ≥3 WU, or mPAP 25-34 mmHg) (CLD-PH).; CLD with severe PH (mPAP ≥35 mmHg, or mPAP ≥25 mmHg with low cardiac index (<2.0 L·min-1·m-2)) (CLD-severe PH).	within 36 months

Collaborators and Investigators

• Sponsor: Ludwig Boltzmann Institute for Lung Vascular Research
• Collaborators: Medical University of Graz; Medical University of Vienna
• Investigators: Principal Investigator: Leigh Marsh, Ludwig Boltzmann Institute for Lung Vascular Research

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Respiratory Tract Diseases; Vascular Diseases; Lung Diseases
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Hypertension; Lung Diseases; Hypertension, Pulmonary
• Other Study ID Numbers: LBILVR-KLI 884-B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No