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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат blood sampling
  22mL peripheral blood will be collected
• Биопрепарат broncho-alveolar lavage sampling
  Collected on resected tissue
• Биопрепарат lung parenchyma sampling
  Collected on resected tissue

Первичные конечные точки

• Percentage of pulmonary artery media thickness measured by optical microscopy [Срок оценки: Surgical intervention]

Вторичные конечные точки (9)

• Quantify endovascular (angiophagy) and perivascular (fibrosis, pro-inflammatory cells) tissue lesions. [Срок оценки: Surgical intervention]
• Compare the radiological phenotyping of patients with pulmonary hypertension and without pulmonary hypertension, determined from patient lung scans [Срок оценки: Baseline]
• Compare cardiorespiratory functional clinical phenotyping between patients with pulmonary hypertension and without pulmonary hypertension. [Срок оценки: Baseline]
• Compare the biological phenotyping of biological lung inflammation from bronchioloalveolar lavage of patients with pulmonary hypertension and without pulmonary hypertension. [Срок оценки: Surgical intervention]
• High-throughput proteomic quantification indices of circulating serum from patients with pulmonary hypertension compared with patients without pulmonary hypertension. [Срок оценки: Baseline]
• Compare the phenotyping of pulmonary vascular microstructure by microCT in patients with pulmonary hypertension and without pulmonary hypertension. [Срок оценки: 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. [Срок оценки: Surgical intervention]
• Evaluate the statistical relationships between tissue vascular remodeling and tissue, alveolar, and blood protein alterations. [Срок оценки: 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. [Срок оценки: Surgical intervention]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07184671 · 2025-A00420-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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