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Inflammatory Profiling in Chronic Lung Disease

Inflammatory Profiling in Chronic Lung Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04654767
Enrollment
60
Registered
2020-12-04
Start date
2021-12-01
Completion date
2025-06-30
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Vascular Diseases, Lung Diseases, Respiratory Tract Diseases

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.

Interventions

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.

Sponsors

Medical University of Graz
CollaboratorOTHER
Medical University of Vienna
CollaboratorOTHER
Ludwig Boltzmann Institute for Lung Vascular Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Analysis of inflammatory cell profilewithin 36 monthsThe 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

MeasureTime frameDescription
Degree of pulmonary vascular diseasewithin 36 monthsPulmonary 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).

Countries

Austria

Contacts

Primary ContactLeigh Marsh
leigh.marsh@lvr.lbg.ac.at+4331638572911

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026