Inflammatory Profiling in Chronic Lung Disease

Pulmonary Hypertension Clinical Trial

Official title:

Inflammatory Profiling in Chronic Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654767
• Other study ID #: LBILVR-KLI 884-B
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Ludwig Boltzmann Institute for Lung Vascular Research
• Contact: Leigh Marsh
• Phone: +4331638572911
• Email: leigh.marsh[@]lvr.lbg.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Lung Diseases
• Pulmonary Hypertension

Intervention

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.

Locations

Country	Name	City	State
Austria	Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna	Vienna

Sponsors (3)

Lead Sponsor	Collaborator
Ludwig Boltzmann Institute for Lung Vascular Research	Medical University of Graz, Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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