Treatment for Nonthrombotic Obstructive Pulmonary Hypertension

Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study

This study is testing if a new treatment combining a special injection and a procedure can help people with a specific type of lung high blood pressure feel better compared to just the procedure alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Beijing Chao Yang Hospital (Academic / other)
• Drugs / interventions: rituximab
• Locations: 1 site (Beijing)
• Trial ID: NCT06980584 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular intervention in patients with fibrosing mediastinal pulmonary hypertension. Participants are randomly assigned to receive either the combined treatment or pulmonary vascular intervention alone. The study assesses outcomes such as symptom improvement, hemodynamic changes, and lesion volume reduction at 3, 6, and 12 months post-treatment. Safety is evaluated by comparing the incidence of adverse events between the two groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 diagnosed with fibrosing mediastinitis and experiencing symptoms like chest tightness and shortness of breath.

Not a fit: Patients with active infections, uncontrolled primary diseases, significant pleural effusion, or severely impaired pulmonary function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve symptoms and quality of life for patients with fibrosing mediastinal pulmonary hypertension.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in treating pulmonary hypertension with combined therapies.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Chaoyang Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Juanni Gong, Doctor of Medicine

Conditions Fibrosing Mediastinitis; Pulmonary Hypertension; Rituximab; Endobronchial Ultrasound; Pulmonary Vascular Intervention