Clinical, Radiological, Tissue and Biological Phenotyping for the Analysis of the Transition From Physiology to Pathology in Pulmonary Diseases With Pulmonary Hypertension

NCT07184671 | Not Yet Recruiting

• 1 other identifier: 2025-A00420-49
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Pulmonary hypertension; chronic pulmonary disease; Phenotyping; Vascular remodeling

Outcome Measures

Primary Outcomes (1)

• Percentage of pulmonary artery media thickness measured by optical microscopy

  Surgical intervention

Secondary Outcomes (9)

• Quantify endovascular (angiophagy) and perivascular (fibrosis, pro-inflammatory cells) tissue lesions.

  Surgical intervention

• Compare the radiological phenotyping of patients with pulmonary hypertension and without pulmonary hypertension, determined from patient lung scans

  Baseline

• Compare cardiorespiratory functional clinical phenotyping between patients with pulmonary hypertension and without pulmonary hypertension.

  Baseline

• Compare the biological phenotyping of biological lung inflammation from bronchioloalveolar lavage of patients with pulmonary hypertension and without pulmonary hypertension.

  Surgical intervention

• High-throughput proteomic quantification indices of circulating serum from patients with pulmonary hypertension compared with patients without pulmonary hypertension.

  Baseline

Study Arms (3)

Patients with chronic pulmonary disease and pulmonary hypertension

Patients on the lung transplant list with chronic pulmonary disease and pulmonary hypertension

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.

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.

Biological: blood sampling; Biological: broncho-alveolar lavage sampling; Biological: lung parenchyma sampling

Interventions

blood sampling BIOLOGICAL

22mL peripheral blood will be collected

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 sampling BIOLOGICAL

Collected on resected tissue

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 sampling BIOLOGICAL

Collected on resected tissue

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment will be carried out on a continuous, daily basis in the thoracic surgery department of the Hôpital Nord in Marseille.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

MeSH Terms

Conditions

Hypertension, Pulmonary; Vascular Remodeling

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 22, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09