NCT06980584 Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
| NCT ID | NCT06980584 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Chao Yang Hospital |
| Condition | Fibrosing Mediastinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2025-02-10 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: 1. Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years. 2. The patient presented with symptoms of chest tightness, shortness of breath, and reduced exercise tolerance. 3. Chest CT revealed mediastinal lymph node compression of the pulmonary artery, with evidence of pulmonary hypertension consistent with the patient's symptoms. 4. 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: 1. Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections; 2. The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled. 3. Before treatment, a large amount of pleural effusion was still present. 4. Pulmonary function tests (PFT) showed FEV1 \<30% of the predicted value, FEV1/FVC \<30%, and DLCO \<30%. 5. There are contraindications to bronchoscopy or endovascular intervention. 6. Complicated by other end-stage organ dysfunction, such as Child-Pugh class C liver function or stage IV chronic renal failure. 7. Complicated by severe immunosuppression.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06980584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Fibrosing Mediastinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06980584 currently recruiting?
Yes, NCT06980584 is actively recruiting participants. Contact the research team at juannigong2018@126.com for enrollment information.
Where is the NCT06980584 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06980584 clinical trial?
NCT06980584 is sponsored by Beijing Chao Yang Hospital. The trial plans to enroll 48 participants.