Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension (NCT06980584) | Clinical Trial Compass
RecruitingNot Applicable
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
China48 participantsStarted 2025-02-10
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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%.
What they're measuring
1
Change from Baseline in the Six Minutes Walk Distance at 12 Months.
Timeframe: From enrollment to the end of treatment at 12 months
2
The incidence of treatment-related serious adverse events (SAE)
Timeframe: During the one-year follow-up period after treatment completion