Exploring Blood Cell Function and Oxidative Stress to Improve Diagnosis and Treatment in Pre-Capillary Pulmonary Hypertension

Официальное название

Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration in Pre-Capillary Pulmonary Hypertension

Обзор

This study aims to understand how blood cell (including peripheral blood mononuclear cells ((PBMCs) or platelets) function and oxidative stress can help physicians detect and predict the course of pre-capillary pulmonary hypertension. We hypothesize that changes in the mitochondrial function of blood cells and oxidative stress may be early markers of disease progression and severity. The study will also explore how these blood markers relate to routine clinical and heart function measurements, such as echocardiography, right heart catheterization, 6-minute walk tests, and functional status, to see if they can help monitor patients over time and guide personalized care. This is a non-interventional study. Blood samples will be collected during routine visits planned for diagnosis and follow-up. The study will include 120 patients diagnosed with pre-capillary pulmonary hypertension, who will be followed for 3 years. Blood samples will be taken up to three times per year to measure mainly oxidative stress and mitochondrial function in blood cells. These measurements will be compared with clinical tests to see if they can help predict the course of the disease.

Вмешательства

• Другое Patients with pre-Capillary pulmonary hypertension
  Patients will be followed for 3 years with routine clinical, hemodynamic, and laboratory assessments. Blood samples for oxidative stress and mitochondrial function analyses will be collected during scheduled follow-up visits or catheterization procedures. No intervention beyond standard care will be performed.

Первичные конечные точки

• Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers [Срок оценки: 3 years]

Вторичные конечные точки (1)

• Correlation of blood cell mitochondrial function and respirations and oxidative stress markers [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Adult patients (≥18 years) diagnosed with pre-capillary pulmonary hypertension confirmed by right heart catheterization
• Patients classified according to the international clinical classification:

• Group 1: Pulmonary arterial hypertension (PAH)
• Group 3: Pulmonary hypertension associated with chronic respiratory diseases and/or hypoxia
• Group 4: Chronic thromboembolic pulmonary hypertension (CTEPH)
• Patients scheduled for routine clinical follow-up and/or right heart catheterization at the study center.
• Ability and willingness to provide informed consent for participation and data analysis.

Критерии исключения

• Postcapillary pulmonary hypertension (pulmonary arterial wedge pressure >15 mmHg).
• Conditions precluding safe blood sampling (e.g., severe anemia, coagulopathy).
• Patients already enrolled in interventional clinical trials that could interfere with mitochondrial or oxidative stress measurements
• Patients unable or unwilling to provide informed consent
• Pregnancy or breastfeeding

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Hôpitaux Universitaires de Strasbourg - Service Physiologie explorations fonctionnelles — Strasbourg

Идентификаторы

NCT: NCT07176260 · CE 2017-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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