Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Six Minutes Walk Distance at 12 Months.
研究概览
简要总结
Through a randomized controlled trial (RCT) design, this study aiming to evaluated the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular interventional therapy in treating fibrosing mediastinal pulmonary hypertension (FM-PH).Eligible participants were randomly assigned to either the combined treatment group, receiving both pulmonary vascular intervention and rituximab lymph node injection, or the interventional-only group, which received pulmonary vascular intervention alone. At 3, 6, and 12 months post-treatment, the efficacy was assessed based on symptom improvement, hemodynamic changes, lesion volume reduction, etc. Safety was mainly evaluated by comparing adverse event incidence between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years.
- •The patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance.
- •Chest CT revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms.
- •The subject signed the informed consent form prior to participation and is able to comply with the study protocol and one-year follow-up.
排除标准
- •Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections;
- •The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled.
- •Before treatment, a large amount of pleural effusion was still present.
- •Pulmonary function tests (PFT) showed FEV1 <30% of the predicted value, FEV1/FVC <30%, and DLCO <30%.
- •There are contraindications to bronchoscopy or endovascular intervention.
- •Complicated by other end-stage organ dysfunction, such as Child-Pugh class C liver function or stage IV chronic renal failure.
- •Complicated by severe immunosuppression.
研究组 & 干预措施
Combined treatment group
Participants assigned to this group will receive both pulmonary vascular intervention and rituximab lymph node injection.
干预措施: Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention (Procedure)
Interventional-only group
Participants assigned to this group will receive pulmonary vascular intervention alone.
干预措施: Pulmonary Vascular Interventional Therapy (Procedure)
结局指标
主要结局
Change from Baseline in the Six Minutes Walk Distance at 12 Months.
时间窗: From enrollment to the end of treatment at 12 months
Conduct 6-minute walk test to measure the 6-minute walk distance, and compare the walking distances at baseline and 12 months after treatment.
The incidence of treatment-related serious adverse events (SAE)
时间窗: During the one-year follow-up period after treatment completion
The incidence of treatment-related serious adverse events is measured by tracking and documenting any SAEs that occur during the treatment period, as well as through follow-up assessments. Each event is evaluated for severity and causality, and the incidence is calculated by dividing the number of patients who experience at least one treatment-related SAE by the total number of treated patients.
次要结局
- Change from baseline in the World Health Organization Functional Classification of Pulmonary Hypertension at 3, 6 and 12 months.(From enrollment to the end of treatment at 3, 6 and 12 months.)
- Change from Baseline in the mean pulmonary artery pressure (mPAP) at 3 and 12 Months.(From enrollment to the end of treatment at 3 and12 months)
- Change from Baseline in the Cardiac Index (CI) at 3 and 12 Months.(From enrollment to the end of treatment at 3 and12 months)
- Change from Baseline in the Pulmonary Vascular Resistance (PVR) at 3 and 12 Months.(From enrollment to the end of treatment at 3 and12 months)
- Change from Baseline in the forced vital capacity (FVC) at 3, 6 and 12 Months.(From enrollment to the end of treatment at 3, 6 and 12 months)
- Change from Baseline in the forced vital capacity of predicted (FVC%pred) at 3, 6 and 12 Months.(From enrollment to the end of treatment at 3, 6 and 12 months)
- Change from Baseline in the forced expiratory volume in 1 second (FEV1) at 3, 6 and 12 Months.(From enrollment to the end of treatment at 3, 6 and 12 months)
- Change from Baseline in the forced expiratory volume in 1 second of predicted (FEV1%pred) at 3, 6 and 12 Months.(From enrollment to the end of treatment at 3, 6 and 12 months)
- Change from Baseline in the FEV1/FVC ratio at 3, 6 and 12 Months.(From enrollment to the end of treatment at 3, 6 and 12 months)
- Change of the BNP/NT-Pro BNP from baseline to the end of treatment at 3, 6 and 12 months.(From enrollment to the end of treatment at 3, 6 and 12 months.)
- The restenosis rate of blood vessels after interventional therapy at the end of treatment at 3 and 12 months(From enrollment to the end of treatment at 3 and 12 months.)
- Change of the mediastinal lesion volume from baseline to 3 and 12 months after the end of treatment.(From enrollment to the end of treatment at 3 and12 months.)
- Change from baseline of the quality-of-life score at 3, 6 and 12 months after the end of treatment.(From enrollment to the end of treatment at 3, 6 and 12 months)
- Number of participants with complications of bronchoscopy and pulmonary intervention.(Immediately or in the short term after treatment, and within 12 months after treatment)