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RECRUITING
NCT06980584
NA

Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

Sponsor: Beijing Chao Yang Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-02-10

Completion Date

2027-10-31

Last Updated

2025-05-23

Healthy Volunteers

No

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.

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China