Inflammatory Profiling in Chronic Lung Disease

Recruiting

• Conditions: Pulmonary Hypertension
• Interventions: Other: Tissue sampling

• Registration Number: NCT04654767
• Lead Sponsor: Ludwig Boltzmann Institute for Lung Vascular Research

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.

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 Timeline

• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Study Start: 2021-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Tissue sampling	Control group without diagnosed COPD, IPF, or pulmonary hypertension
COPD-PH group	Tissue sampling	Patients with confirmed COPD and pulmonary hypertension
IPF-PH	Tissue sampling	Patients with confirmed pulmonary fibrosis and pulmonary hypertension

Primary Outcome Measures

Name	Time	Method
Analysis of inflammatory cell profile	within 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Degree of pulmonary vascular disease	within 36 months	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).

Trial Locations

Locations (1)

Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna; 🇦🇹 Vienna, Austria