Pulmonary HypertensionPHENOPULMNCT07184671
Clinical, Radiological, Tissue and Biological Phenotyping for the Analysis of the Transition From Physiology to Pathology in Pulmonary Diseases With Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Chronic Pulmonary Disease, run by Assistance Publique Hopitaux De Marseille.
Trial summary
This is a monocentric, case-control, comparative study aiming at investigating the transition from physiological to pathological pulmonary circulation in patients with pulmonary hypertension (PH) and chronic lung diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Chronic Pulmonary Disease
- What is being tested?
- blood sampling, broncho-alveolar lavage sampling and lung parenchyma sampling
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Recruitment will be carried out on a continuous, daily basis in the thoracic surgery department of the Hôpital Nord in Marseille.
Who may be able to join
- Male or female over 18 years of age
- Patient who has received information about the study and has not expressed any objection
- Patient who is a beneficiary or entitled person under a social security scheme
- Patient requiring thoracic surgery for an acute or chronic acquired pathology with planned resection of lung parenchyma.
- Group A: patients on the lung transplant list with chronic lung disease and pulmonary hypertension*.
- Group B: control patients with chronic lung disease without pulmonary hypertension on the lung transplant list or with an indication for lung resection surgery for diagnostic or therapeutic purposes.
- Group C: control patients without chronic lung disease or pulmonary hypertension with an indication for lung resection.
- Pulmonary hypertension is defined by a mean resting pulmonary arterial pressure of 20 mmHg and pulmonary vascular resistances > 2UW and an occlusion pulmonary arterial pressure ≤ 15 mmHg.
Who cannot join
- Person in exclusion period from another research protocol at the time the no-objection is collected
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women).
About this study
Official title: Clinical, Radiological, Tissue and Biological Phenotyping for the Analysis of the Transition From Physiology to Pathology in Pulmonary Diseases With Pulmonary Hypertension.
This is a monocentric, case-control, comparative study aiming at investigating the transition from physiological to pathological pulmonary circulation in patients with pulmonary hypertension (PH) and chronic lung diseases. The study will include 105 adults participants undergoing lung surgery, divided into three groups, Group A (patients with chronic lung disease and PH undergoing lung transplantation), Group B (patients with chronic lung disease without PH), and Group C (patients without chronic lung disease nor PH). The primary objective is to identify the association between vascular remodeling and PH by measuring the medial thickness of pulmonary arteries. Secondary objectives include multimodal phenotyping (clinical, radiological, tissue, and biological) to explore mechanisms of PH development. Blood, broncho-alveolar lavage, and lung tissue samples will be collected during routine care. The study aims to improve understanding of PH pathophysiology and identify potential biomarkers and therapeutic targets.
- Conditions
- Pulmonary Hypertension, Chronic Pulmonary Disease
- Being tested
- blood sampling, broncho-alveolar lavage sampling, lung parenchyma sampling
- Keywords
- Pulmonary hypertension, chronic pulmonary disease, Phenotyping, Vascular remodeling
- Medical subject headings
- Hypertension, Pulmonary, Vascular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
22mL peripheral blood will be collected
broncho-alveolar lavage samplingBiological
Collected on resected tissue
lung parenchyma samplingBiological
Collected on resected tissue
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic pulmonary disease and pulmonary hypertension | Patients on the lung transplant list with chronic pulmonary disease and pulmonary hypertension Receives: Biological: blood sampling; Biological: broncho-alveolar lavage sampling; Biological: lung parenchyma sampling | |
| Control patients with chronic pulmonary disease without pulmonary hypertension | Control patients with chronic pulmonary disease without pulmonary hypertension on the lung transplant list or with an indication for lung resection surgery for diagnostic or therapeutic purposes. Receives: Biological: blood sampling; Biological: broncho-alveolar lavage sampling; Biological: lung parenchyma sampling | |
| Control patients without chronic pulmonary disease or pulmonary hypertension | Control patients without chronic pulmonary disease or pulmonary hypertension with an indication for lung resection. Receives: Biological: blood sampling; Biological: broncho-alveolar lavage sampling; Biological: lung parenchyma sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pulmonary artery media thickness measured by optical microscopy
Measured: Surgical intervention
Secondary outcomes (9)
Quantify endovascular (angiophagy) and perivascular (fibrosis, pro-inflammatory cells) tissue lesions.
number of stage I, II and III angiophagia lesions relative to the number of arteries analyzed on a field of anatomopathology slides and classified according to artery diameter; surface area of pulmonary fibrosis relative to the total surface area of the tissue field explored; quantification of immune system cells in interstitial tissue relative to the tissue surface area explored.
Measured: Surgical intervention
Compare the radiological phenotyping of patients with pulmonary hypertension and without pulmonary hypertension, determined from patient lung scans
Measured: Baseline
Compare cardiorespiratory functional clinical phenotyping between patients with pulmonary hypertension and without pulmonary hypertension.
Using generalized linear model for assesment of respiratory function tests, 6-minute walk test and echocardiography of patients
Measured: Baseline
Compare the biological phenotyping of biological lung inflammation from bronchioloalveolar lavage of patients with pulmonary hypertension and without pulmonary hypertension.
Dosage of inflammatory proteins (IL1, IL10, IL6, etc.) and cytological analysis of bronchioloalveolar lavage
Measured: Surgical intervention
High-throughput proteomic quantification indices of circulating serum from patients with pulmonary hypertension compared with patients without pulmonary hypertension.
Measured: Baseline
Compare the phenotyping of pulmonary vascular microstructure by microCT in patients with pulmonary hypertension and without pulmonary hypertension.
Measured: Surgical intervention
Compare protein tissue phenotyping of pulmonary hypertension regulatory pathways in patients with and without pulmonary hypertension evaluated with Elisa tests on lung parenchyma.
Measured: Surgical intervention
Evaluate the statistical relationships between tissue vascular remodeling and tissue, alveolar, and blood protein alterations.
Measured: Baseline and surgical intervention
Compare genetic tissue phenotyping of pulmonary hypertension regulatory pathways in patients with and without pulmonary hypertension evaluated with PCR tests on lung parenchyma.
Measured: Surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184671
- Sponsor's protocol ID
- 2025-A00420-49
- Acronym
- PHENOPULM
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological, Tissue and Biological Phenotyping for the Analysis of the Transition From Physiology to Pathology in Pulmonary Diseases With Pulmonary Hypertension.
- ClinicalTrials.gov ID
- NCT07184671
- Acronym / sponsor ID
- PHENOPULM / 2025-A00420-49
- Conditions
- Pulmonary Hypertension, Chronic Pulmonary Disease
- Keywords
- Pulmonary hypertension, chronic pulmonary disease, Phenotyping, Vascular remodeling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Sep 2025 (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.
This is a monocentric, case-control, comparative study aiming at investigating the transition from physiological to pathological pulmonary circulation in patients with pulmonary hypertension (PH) and chronic lung diseases. The study will include 105 adults participants undergoing lung surgery, divided into three groups, Group A (patients with chronic lung disease and PH undergoing lung transplantation), Group B (patients with chronic lung disease without PH), and Group C (patients without chronic lung disease nor PH). The primary objective is to identify the association between vascular remodeling and PH by measuring the medial thickness of pulmonary arteries. Secondary objectives include multimodal phenotyping (clinical, radiological, tissue, and biological) to explore mechanisms of PH development. Blood, broncho-alveolar lavage, and lung tissue samples will be collected during routine care. The study aims to improve understanding of PH pathophysiology and identify potential biomarkers and therapeutic targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic pulmonary disease and pulmonary hypertension | – | Biological: blood sampling, Biological: broncho-alveolar lavage sampling, Biological: lung parenchyma samplingPatients on the lung transplant list with chronic pulmonary disease and pulmonary hypertension |
| Control patients with chronic pulmonary disease without pulmonary hypertension | – | Biological: blood sampling, Biological: broncho-alveolar lavage sampling, Biological: lung parenchyma samplingControl patients with chronic pulmonary disease without pulmonary hypertension on the lung transplant list or with an indication for lung resection surgery for diagnostic or therapeutic purposes. |
| Control patients without chronic pulmonary disease or pulmonary hypertension | – | Biological: blood sampling, Biological: broncho-alveolar lavage sampling, Biological: lung parenchyma samplingControl patients without chronic pulmonary disease or pulmonary hypertension with an indication for lung resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be carried out on a continuous, daily basis in the thoracic surgery department of the Hôpital Nord in Marseille.
Key inclusion criteria (8 listed)
- Male or female over 18 years of age
- Patient who has received information about the study and has not expressed any objection
- Patient who is a beneficiary or entitled person under a social security scheme
- Patient requiring thoracic surgery for an acute or chronic acquired pathology with planned resection of lung parenchyma.
- Group A: patients on the lung transplant list with chronic lung disease and pulmonary hypertension*.
Key exclusion criteria (2 listed)
- Person in exclusion period from another research protocol at the time the no-objection is collected
- Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling22mL peripheral blood will be collected | Biological | Control patients with chronic pulmonary disease without pulmonary hypertension, Control patients without chronic pulmonary disease or pulmonary hypertension, Patients with chronic pulmonary disease and pulmonary hypertension |
| broncho-alveolar lavage samplingCollected on resected tissue | Biological | Control patients with chronic pulmonary disease without pulmonary hypertension, Control patients without chronic pulmonary disease or pulmonary hypertension, Patients with chronic pulmonary disease and pulmonary hypertension |
| lung parenchyma samplingCollected on resected tissue | Biological | Control patients with chronic pulmonary disease without pulmonary hypertension, Control patients without chronic pulmonary disease or pulmonary hypertension, Patients with chronic pulmonary disease and pulmonary hypertension |
Primary outcome
Percentage of pulmonary artery media thickness measured by optical microscopy
Time frame: Surgical intervention
9 secondary outcomes
Quantify endovascular (angiophagy) and perivascular (fibrosis, pro-inflammatory cells) tissue lesions.
Time frame: Surgical intervention
Compare the radiological phenotyping of patients with pulmonary hypertension and without pulmonary hypertension, determined from patient lung scans
Time frame: Baseline
Compare cardiorespiratory functional clinical phenotyping between patients with pulmonary hypertension and without pulmonary hypertension.
Time frame: Baseline
Compare the biological phenotyping of biological lung inflammation from bronchioloalveolar lavage of patients with pulmonary hypertension and without pulmonary hypertension.
Time frame: Surgical intervention
High-throughput proteomic quantification indices of circulating serum from patients with pulmonary hypertension compared with patients without pulmonary hypertension.
Time frame: Baseline
Compare the phenotyping of pulmonary vascular microstructure by microCT in patients with pulmonary hypertension and without pulmonary hypertension.
Time frame: Surgical intervention
Compare protein tissue phenotyping of pulmonary hypertension regulatory pathways in patients with and without pulmonary hypertension evaluated with Elisa tests on lung parenchyma.
Time frame: Surgical intervention
Evaluate the statistical relationships between tissue vascular remodeling and tissue, alveolar, and blood protein alterations.
Time frame: Baseline and surgical intervention
Compare genetic tissue phenotyping of pulmonary hypertension regulatory pathways in patients with and without pulmonary hypertension evaluated with PCR tests on lung parenchyma.
Time frame: Surgical intervention
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 22 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Chronic Pulmonary Disease, run by Assistance Publique Hopitaux De Marseille.
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 8 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: opening soon, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pulmonary artery media thickness measured by optical microscopy (time frame: Surgical intervention). 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 22 Sep 2025.