Inflammatory Profiling in Chronic Lung Disease

NCT ID: NCT04654767

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-06-30

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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD-PH group

Patients with confirmed COPD and pulmonary hypertension

Tissue sampling

Intervention Type OTHER

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.

IPF-PH

Patients with confirmed pulmonary fibrosis and pulmonary hypertension

Tissue sampling

Intervention Type OTHER

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.

Control group

Control group without diagnosed COPD, IPF, or pulmonary hypertension

Tissue sampling

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role collaborator

Ludwig Boltzmann Institute for Lung Vascular Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Leigh Marsh

Role: PRINCIPAL_INVESTIGATOR

Ludwig Boltzmann Institute for Lung Vascular Research

Locations

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

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Leigh Marsh

Role: CONTACT

+4331638572911

Facility Contacts

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Walter Klepetko, Prof

Role: primary

0043140400 ext. 56440

Elisabeth Gschwandtner, Dr

Role: backup

0043140400 ext. 56440

Other Identifiers

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LBILVR-KLI 884-B

Identifier Type: -

Identifier Source: org_study_id

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