Pulmonary HypertensionNCT04654767
Inflammatory Profiling in Chronic Lung Disease
An observational study of Pulmonary Hypertension, run by Ludwig Boltzmann Institute for Lung Vascular Research at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Tissue sampling
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects undergoing lung transplantation at the Medical University of Vienna
Who may be able to join
- Patients undergoing lung transplant with COPD or IPF, with associated PH
- Signed informed consent
Who cannot join
- patients without written informed consent
- Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna
Vienna, 1090
Walter Klepetko, Prof, 0043140400 ext. 56440, walter.klepetko@meduniwien.ac.at
Elisabeth Gschwandtner, Dr, 0043140400 ext. 56440, elisabeth.gschwandtner@meduniwien.ac.at
About this study
The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Tissue sampling
- Keywords
- Vascular Diseases, Lung Diseases, Respiratory Tract Diseases
- Medical subject headings
- Hypertension, Pulmonary, Vascular Diseases, Lung Diseases, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COPD-PH group | Patients with confirmed COPD and pulmonary hypertension Receives: Other: Tissue sampling | |
| IPF-PH | Patients with confirmed pulmonary fibrosis and pulmonary hypertension Receives: Other: Tissue sampling | |
| Control group | Control group without diagnosed COPD, IPF, or pulmonary hypertension Receives: Other: Tissue sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 36 months
Secondary outcomes (1)
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).
Measured: within 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Dec 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Lung Vascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz, Medical University of Vienna
- Responsible party
- Sponsor
- Investigators
- Leigh Marsh, Principal investigator, Ludwig Boltzmann Institute for Lung Vascular Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654767
- Sponsor's protocol ID
- LBILVR-KLI 884-B
- Status last verified
- Apr 2024
- First submitted
- 25 Nov 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Profiling in Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT04654767
- Acronym / sponsor ID
- LBILVR-KLI 884-B
- Conditions
- Pulmonary Hypertension
- Keywords
- Vascular Diseases, Lung Diseases, Respiratory Tract Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ludwig Boltzmann Institute for Lung Vascular ResearchUniversity, hospital or other
- Collaborators
- Medical University of Graz, Medical University of Vienna
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD-PH group | – | Other: Tissue samplingPatients with confirmed COPD and pulmonary hypertension |
| IPF-PH | – | Other: Tissue samplingPatients with confirmed pulmonary fibrosis and pulmonary hypertension |
| Control group | – | Other: Tissue samplingControl group without diagnosed COPD, IPF, or pulmonary hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing lung transplantation at the Medical University of Vienna
Key inclusion criteria (2 listed)
- Patients undergoing lung transplant with COPD or IPF, with associated PH
- Signed informed consent
Key exclusion criteria (2 listed)
- patients without written informed consent
- Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue samplingBlood 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. | Other | COPD-PH group, Control group, IPF-PH |
Primary outcome
Analysis of inflammatory cell profile
Time frame: 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.
1 secondary outcome
Degree of pulmonary vascular disease
Time frame: within 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Marsh principal investigator
Ludwig Boltzmann Institute for Lung Vascular Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Ludwig Boltzmann Institute for Lung Vascular Research at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leigh Marsh (+4331638572911, leigh.marsh@lvr.lbg.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of inflammatory cell profile (time frame: within 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024; AzTrials last refreshed its copy on 3 Nov 2026.