Collagen Fingerprinting for Stratification of PH Patients

NCT07498244 | Recruiting

• 1 other identifier: 10.55776/KLP3022825
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic lung diseases like pulmonary fibrosis and COPD (Chronic Obstructive Pulmonary Disease) can lead to pulmonary hypertension, a serious complication where increased pressure in lung vessels strains the heart and worsens outcomes. Because early symptoms are unclear, diagnosis often comes too late, highlighting the need for simple, non-invasive early detection methods. A key driver of the disease is vascular remodeling, where blood vessels narrow and stiffen. This involves changes in the extracellular matrix, particularly 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, we aim to identify non-invasive biomarkers for earlier diagnosis, better patient classification, and more personalized treatment.

Conditions

Pulmonary Hypertension Due to Lung Diseases

Keywords

Collagens

Outcome Measures

Primary Outcomes (1)

• Analysis of collagen fragments

  Fragments will be measured in plasma/serum/tissue by ELISA/Mass Spectrometry or single cell analysis.

  within 48 months

Secondary Outcomes (1)

• Disease severity score

  within 48 months

Study Arms (4)

COPD/PH group: Patients with confirmed COPD with or without pulmonary hypertension

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.

PF/PH group: Patients with confirmed pulmonary fibrosis with or without pulmonary hypertension

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.

IPAH group: Patients with confirmed pulmonary arterial hypertension

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.

Control group: Control group without diagnosed COPD, PF or pulmonary hypertension

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing lung transplantation with COPD or PF with and without associated PH and IPAH Outpatient cohort with COPD or PF with and without associated PH and IPAH

You may qualify if:

• Patients undergoing lung transplantation with COPD or PF with and without associated PH and IPAH
• Outpatient cohort with COPD or PF with and without associated PH and IPAH

You may not qualify if:

• existence of other lung diseases
• signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.

Sponsors & Collaborators

• Medical University of Graz: lead
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples, explant lung tissue

Study Officials

• Nikolaus Kneidinger, MD

  Medical University of Graz

  STUDY CHAIR

Central Study Contacts

Grazyna Kwapiszewska-Marsh, PhD

CONTACT

004331638572918; grazyna.kwapiszewska-marsh@medunigraz.at

Johannes Lorenz Berg, PhD

CONTACT

004331638572917; johannes.berg@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

AU (1)