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Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients

Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07498244
Enrollment
80
Registered
2026-03-27
Start date
2026-07-01
Completion date
2030-06-30
Last updated
2026-04-03

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

Conditions

Pulmonary Hypertension Due to Lung Diseases

Keywords

Collagens

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Medical University of Graz
Lead SponsorOTHER
Medical University of Vienna
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Analysis of collagen fragmentswithin 48 monthsThe fragments will be measured in the plasma, serum, or tissue using an enzyme-linked immunosorbent assay (ELISA), mass spectrometry, or single-cell analysis.

Secondary

MeasureTime frameDescription
Disease severity assessmentwithin 48 monthsThe 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.

Countries

Austria

Contacts

CONTACTGrazyna Kwapiszewska-Marsh, PhD
grazyna.kwapiszewska-marsh@medunigraz.at004331638572918
CONTACTJohannes Lorenz Berg, PhD
johannes.berg@medunigraz.at004331638572917
STUDY_CHAIRNikolaus Kneidinger, MD

Medical University of Graz

Outcome results

None listed

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