Pulmonary Hypertension Due to Lung DiseasesNCT07498244
Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients
An observational study of Pulmonary Hypertension Due to Lung Diseases, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension Due to Lung Diseases
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2026to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Presence of other lung diseases
- Signs of infection, such as pneumonia, pulmonary tuberculosis, or pleural effusions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8010
Nikolaus Kneidinger, MD, 004331638513305, nikolaus.kneidinger@medunigraz.at
About this study
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.
Read the 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.
- Keywords
- Collagens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with confirmed COPD with or without pulmonary hypertension (COPD/PH group) | Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Obtain explant lung tissue from patients who have undergone lung transplantation. | |
| Patients with confirmed pulmonary fibrosis with or without pulmonary hypertension (PF/PH group) | Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Obtain explant lung tissue from patients who have undergone lung transplantation. | |
| Patients with confirmed pulmonary arterial hypertension (PAH group) | Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Obtain explant lung tissue from patients who have undergone lung transplantation. | |
| Control group without diagnosed COPD, PF or pulmonary hypertension (Control group) | Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Explant lung tissue is obtained from patients who have undergone lung transplantation. Non-transplanted donor lungs that were harvested for transplantation but not implanted due to size reduction serve as controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Due to Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna
- Responsible party
- Sponsor
- Investigators
- Nikolaus Kneidinger, MD, Study chair, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498244
- Sponsor's protocol ID
- 10.55776/KLP3022825
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collagen Fingerprinting for Stratification of Pulmonary Hypertension (PH) Patients
- ClinicalTrials.gov ID
- NCT07498244
- Acronym / sponsor ID
- 10.55776/KLP3022825
- Keywords
- Collagens
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- Medical University of Vienna
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with confirmed COPD with or without pulmonary hypertension (COPD/PH group) | – | –Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Obtain explant lung tissue from patients who have undergone lung transplantation. |
| Patients with confirmed pulmonary fibrosis with or without pulmonary hypertension (PF/PH group) | – | –Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Obtain explant lung tissue from patients who have undergone lung transplantation. |
| Patients with confirmed pulmonary arterial hypertension (PAH group) | – | –Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Obtain explant lung tissue from patients who have undergone lung transplantation. |
| Control group without diagnosed COPD, PF or pulmonary hypertension (Control group) | – | –Tissue Sampling Blood is collected via venipuncture into citrate- or ethylenediaminetetraacetic acid (EDTA)-containing Vacutainer tubes, as well as into serum tubes. Explant lung tissue is obtained from patients who have undergone lung transplantation. Non-transplanted donor lungs that were harvested for transplantation but not implanted due to size reduction serve as controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Presence of other lung diseases
- Signs of infection, such as pneumonia, pulmonary tuberculosis, or pleural effusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Disease severity assessment
Time frame: within 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Hypertension Due to Lung Diseases
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
RecruitingPhase 2
Study of TX000045 in Participants With Pulmonary Hypertension Due to Interstitial Lung Disease
Hypertension, Pulmonary, Lung Diseases, Interstitial
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Recruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
RecruitingPhase 2
LAM-001 for the Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikolaus Kneidinger, MD study chair
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension Due to Lung Diseases, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grazyna Kwapiszewska-Marsh, PhD (004331638572918, grazyna.kwapiszewska-marsh@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of collagen fragments (time frame: within 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.