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NCT Number: NCT07184671

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Blood sampling

Biological

22mL peripheral blood will be collected

broncho-alveolar lavage sampling

Biological

Collected on resected tissue

lung parenchyma sampling

Biological

Collected on resected tissue

Primary outcomes

  1. Percentage of pulmonary artery media thickness measured by optical microscopy

    Time frame: Surgical intervention

Secondary outcomes

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

    Time frame: Surgical intervention

    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.

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

    Time frame: Baseline

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

    Time frame: Baseline

    Using generalized linear model for assesment of respiratory function tests, 6-minute walk test and echocardiography of patients

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

    Time frame: Surgical intervention

    Dosage of inflammatory proteins (IL1, IL10, IL6, etc.) and cytological analysis of bronchioloalveolar lavage

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

    Time frame: Baseline

  6. Compare the phenotyping of pulmonary vascular microstructure by microCT in patients with pulmonary hypertension and without pulmonary hypertension.

    Time frame: Surgical intervention

  7. 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

  8. Evaluate the statistical relationships between tissue vascular remodeling and tissue, alveolar, and blood protein alterations.

    Time frame: Baseline and surgical intervention

  9. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: PHENOPULM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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