Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Chao Yang Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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%.
Trial design
Treatments tested in this trial
- Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention
- Pulmonary Vascular Interventional Therapy
Treatment groups
48 Participants
are divided into 2 treatment groupsSponsors and collaborators
Beijing Chao Yang Hospital
Lead sponsor
Beijing Municipal Health Commission
Collaborator
Source ClinicalTrials.gov