Inflammatory Profiling in Chronic Lung Disease

Ludwig Boltzmann Institute for Lung Vascular Research60 enrolled

Overview

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

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

Conditions

Pulmonary Hypertension

Interventions

Tissue samplingOTHER

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: within 36 months

Secondary Outcomes

Degree of pulmonary vascular disease

Pulmonary vascular disease will be assessed by associated clinical data (mPAP (mmHg), PVR (WU)) 1. CLD without PH (mPAP \<21 mmHg, or mPAP 21-24 mmHg with pulmonary vascular resistance (PVR) \<3 Wood Units (WU)). 2. CLD with PH (mPAP 21-24 mmHg with PVR ≥3 WU, or mPAP 25-34 mmHg) (CLD-PH). 3. 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).

Time frame: within 36 months

Central Contacts

Leigh Marsh

CONTACT

+4331638572911 leigh.marsh@lvr.lbg.ac.at

Data from ClinicalTrials.gov

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