Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedical University of Graz

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Presence of other lung diseases

Signs of infection, such as pneumonia, pulmonary tuberculosis, or pleural effusions.

Trial population

Patients undergoing lung transplantation with COPD or PF, with or without associated PH or PAH. Outpatient cohort with COPD or PF, with or without associated PH or PAH.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 4 trial groups
Group A: Patients with confirmed COPD with or without pulmonary hypertension (COPD/PH group)
Group B: Patients with confirmed pulmonary fibrosis with or without pulmonary hypertension (PF/PH group)
Group C: Patients with confirmed pulmonary arterial hypertension (PAH group)
Group D: Control group without diagnosed COPD, PF or pulmonary hypertension (Control group)

Trial outcomes

Primary outcomes

1

Analysis of collagen fragments

The fragments will be measured in the plasma, serum, or tissue using an enzyme-linked immunosorbent assay (ELISA), mass spectrometry, or single-cell analysis.

Time frame
within 48 months

Secondary outcomes

1

Disease severity assessment

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.

Time frame
within 48 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of Graz

Lead sponsor

Medical University of Vienna

Collaborator