Diagnostic and Prognostic Significance of Circulating Oxidative Stress and Blood Cell Mitochondrial Respiration in Pre-Capillary Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers
时间窗: 3 years
Analyse Blood Cell Mitochondrial Function and Respiration and Oxidative Stress Markers
次要结局
- Correlation of blood cell mitochondrial function and respirations and oxidative stress markers(3 years)