Recruiting

Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

ClinicalTrials.gov IDNCT06980584

PhaseNA

Enrollment48

SponsorBeijing Chao Yang Hospital

Age18 Years – 85 Years

SexALL

I'm interested View official listing

Conditions studied

Fibrosing Mediastinitis, Pulmonary Hypertension

About this study

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.

Interventions

Procedure: Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention — Based on the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed vessels. During the treatment cycle, one lymph node drug injection is administered: 50mg of rituximab is dissolved in 15ml of 5% glucose solution and injected at multiple sites into the identified enlarged mediastinal lymph nodes under ultrasound-guided bronchoscopy.
Procedure: Pulmonary Vascular Interventional Therapy — According to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels.

Primary outcomes

Change from Baseline in the Six Minutes Walk Distance at 12 Months. (From enrollment to the end of treatment at 12 months)
The incidence of treatment-related serious adverse events (SAE) (During the one-year follow-up period after treatment completion)

Eligibility information

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.

Study locations

Beijing Chaoyang Hospital, Capital Medical University, Beijing, China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.