Status:
RECRUITING
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
Lead Sponsor:
Beijing Chao Yang Hospital
Collaborating Sponsors:
Beijing Municipal Health Commission
Conditions:
Fibrosing Mediastinitis
Pulmonary Hypertension
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06980584
Start Date
February 10 2025
End Date
October 31 2027
Last Update
May 23 2025
Active Locations (1)
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1
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China