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Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

RecruitingNAAges 18 Years - 85 YearsAllBeijing Chao Yang Hospital
NCT06980584 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years. 2. The patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance. 3. Chest CT revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms. 4. The subject signed the informed consent form prior to participation and is able to comply with the study protocol and one-year follow-up. Exclusion Criteria: 1. Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections; 2. The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled. 3. Before treatment, a large amount of pleural effusion was still present. 4. Pulmonary function tests (PFT) showed FEV1 \<30% of the predicted value, FEV1/FVC \<30%, and DLCO \<30%. 5. There are contraindications to bronchoscopy or endovascular intervention. 6. Complicated by other end-stage organ dysfunction, such as Child-Pugh class C liver function or stage IV chronic renal failure. 7. Complicated by severe immunosuppression.
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What it tests

  • Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention
  • Pulmonary Vascular Interventional Therapy
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Where

1 site
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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