Actively Recruiting
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
Led by Beijing Chao Yang Hospital · Updated on 2025-05-23
48
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
Sponsors
B
Beijing Chao Yang Hospital
Lead Sponsor
B
Beijing Municipal Health Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years
- Symptoms include chest tightness, shortness of breath, and reduced exercise tolerance
- Chest CT shows mediastinal lymph node compression of the pulmonary artery with pulmonary hypertension consistent with symptoms
- Signed informed consent and able to comply with study protocol and one-year follow-up
You will not qualify if you...
- Active infections including tuberculosis, Histoplasma capsulatum, or Aspergillus
- Uncontrolled primary diseases such as sarcoidosis, Behcet's disease, or IgG4-related disease
- Presence of large pleural effusion before treatment
- Pulmonary function tests showing FEV1 <30% predicted, FEV1/FVC <30%, or DLCO <30%
- Contraindications to bronchoscopy or endovascular intervention
- End-stage organ dysfunction like Child-Pugh class C liver disease or stage IV chronic renal failure
- Severe immunosuppression
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
Actively Recruiting
Research Team
J
Juanni Gong, Doctor of Medicine
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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