NCT06980584

Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fibrosing Mediastinitis
• Pulmonary Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2025-05-20
• Last updated: 2025-05-23

Locations

1 site across 1 country: China