Inflammatory Profiling in Chronic Lung Disease

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

Detailed Description
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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.

Official Title
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Inflammatory Profiling in Chronic Lung Disease

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Other: Tissue sampling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD-PH group<br>Patients with confirmed COPD and pulmonary hypertension | Other: Tissue sampling<br>* 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.<br>|
| IPF-PH<br>Patients with confirmed pulmonary fibrosis and pulmonary hypertension | Other: Tissue sampling<br>* 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.<br>|
| Control group<br>Control group without diagnosed COPD, IPF, or pulmonary hypertension | Other: Tissue sampling<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular Diseases, Lung Diseases, Respiratory Tract Diseases