RecruitingNot ApplicableNCT06980584

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

Sponsor

Beijing Chao Yang Hospital

Enrollment

48 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Pulmonary Hypertension Fibrosing Mediastinitis

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years.
The patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance.
Chest CT revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms.
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 Criteria7

Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections;
The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled.
Before treatment, a large amount of pleural effusion was still present.
Pulmonary function tests (PFT) showed FEV1 \<30% of the predicted value, FEV1/FVC \<30%, and DLCO \<30%.
There are contraindications to bronchoscopy or endovascular intervention.
Complicated by other end-stage organ dysfunction, such as Child-Pugh class C liver function or stage IV chronic renal failure.
Complicated by severe immunosuppression.

Interventions

PROCEDURERituximab 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.

PROCEDUREPulmonary Vascular Interventional Therapy

According to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels.