An observational study in Pulmonary Hypertension, sponsored by Ludwig Boltzmann Institute for Lung Vascular Research. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Ludwig Boltzmann Institute for Lung Vascular Research · Observational
The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 60 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →This is the only study on the registry with Ludwig Boltzmann Institute for Lung Vascular Research as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects undergoing lung transplantation at the Medical University of Vienna
Exclusion Criteria:
Patients with confirmed COPD and pulmonary hypertension
Other: Tissue sampling
Patients with confirmed pulmonary fibrosis and pulmonary hypertension
Other: Tissue sampling
Control group without diagnosed COPD, IPF, or pulmonary hypertension
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.
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.
Time frame: within 36 months
Degree of pulmonary vascular disease
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).
Time frame: within 36 months
Plan to share: Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.