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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Not yet enrolling

Conditions: Chronic Pulmonary Disease; Pulmonary Hypertension

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

Study type: Observational

Funder types: Other

Identifiers

NCT07184671

2025-A00420-49

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female over 18 years of age
2. Patient who has received information about the study and has not expressed any objection
3. Patient who is a beneficiary or entitled person under a social security scheme
4. Patient requiring thoracic surgery for an acute or chronic acquired pathology with planned resection of lung parenchyma.
5. 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.

Exclusion criteria

1. Person in exclusion period from another research protocol at the time the no-objection is collected
2. 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).

Trial design

105 participants in 3 patient groups

Patients with chronic pulmonary disease and pulmonary hypertension

Description:

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

Treatment:

Biological: broncho-alveolar lavage sampling

Biological: blood sampling

Biological: lung parenchyma sampling

Control patients with chronic pulmonary disease without pulmonary hypertension

Description:

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.

Treatment:

Biological: broncho-alveolar lavage sampling

Biological: blood sampling

Biological: lung parenchyma sampling

Control patients without chronic pulmonary disease or pulmonary hypertension

Description:

Control patients without chronic pulmonary disease or pulmonary hypertension with an indication for lung resection.

Treatment:

Biological: broncho-alveolar lavage sampling

Biological: blood sampling

Biological: lung parenchyma sampling