Medical University of Graz
Graz, Styria, 8010, Austria
Location status: Recruiting
Recruiting
NCT Number: NCT07498244
Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients
Chronic lung diseases such as pulmonary fibrosis and chronic obstructive pulmonary disease (COPD) can lead to pulmonary hypertension. This serious complication involves increased pressure in the lung vessels, which strains the heart and worsens outcomes. Since the early symptoms are unclear, diagnosis often occurs too late, underscoring the need for simple, noninvasive methods of early detection.
A key driver of the disease is vascular remodeling, which involves the narrowing and stiffening of blood vessels. This process involves changes in the extracellular matrix, particularly in the understudied basement membrane. Our project examines how specific components, especially non-classical collagens, change during disease progression. As vessels remodel, detectable fragments enter the bloodstream, potentially creating a molecular fingerprint of the disease.
By analyzing lung tissue and blood samples, the investigators aim to identify non-invasive biomarkers for earlier diagnosis, better patient classification, and more personalized treatment.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
Pulmonary hypertension (PH) is a severe complication of chronic lung diseases (CLDs) that significantly worsens patient outcomes. Although extracellular matrix (ECM) remodeling is central to PH pathogenesis, the basement membrane (BM)-a specialized ECM-remains understudied. The BM's dynamic role in lung tissue organization and signaling may provide insight into disease progression and phenotypic heterogeneity.
The investigators hypothesize that BM remodeling and the release of its bioactive components generate a measurable molecular fingerprint reflecting PH onset and progression in CLD. This study aims to prove the concept of using BM-derived fingerprints for disease detection and patient stratification.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients undergoing lung transplantation with COPD or PF, with or without associated PH and PAH.
- Outpatient cohort with COPD or PF, with or without associated PH or PAH.
Exclusion criteria
- Presence of other lung diseases
- Signs of infection, such as pneumonia, pulmonary tuberculosis, or pleural effusions.
Treatment and study plan
Primary outcomes
-
Analysis of collagen fragments
Time frame: within 48 months
The fragments will be measured in the plasma, serum, or tissue using an enzyme-linked immunosorbent assay (ELISA), mass spectrometry, or single-cell analysis.
Secondary outcomes
-
Disease severity assessment
Time frame: within 48 months
The assessment of disease severity will be based on the associated clinical data and compared to the generated collagen fingerprint, as determined by the primary outcome.
Study contacts
Contact information is provided by the study sponsor or research team.
Grazyna Kwapiszewska-Marsh, PhD
CONTACT
Johannes Lorenz Berg, PhD
CONTACT
Sponsors and collaborators
Lead sponsor
Medical University of Graz
Other
Collaborators
- Medical University of Vienna
Registry information
Important dates
- Study start
- 2026
- Primary completion
- 2030
- Study completion
- 2030
- First posted
- Mar 27, 2026
- Registry last updated
- Apr 3, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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