Recruiting NCT06980584
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention, Pulmonary Vascular Interventional Therapy.
- Who it may be relevant to
- Registry conditions: Fibrosing Mediastinitis, Pulmonary Hypertension. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study
Overview
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.
Interventions
- Procedure Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention
Based on the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed vessels. During the treatment cycle, one lymph node drug injection is administered: 50mg of rituximab is dissolved in 15ml of 5% glucose solution and injected at multiple sites into the identified enlarged mediastinal lymph nodes under ultrasound-guided bronchoscopy. - Procedure Pulmonary Vascular Interventional Therapy
According to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels.
Primary outcome measures
- Change from Baseline in the Six Minutes Walk Distance at 12 Months. [Time frame: From enrollment to the end of treatment at 12 months]
- The incidence of treatment-related serious adverse events (SAE) [Time frame: During the one-year follow-up period after treatment completion]
Secondary outcome measures (12)
- Change from baseline in the World Health Organization Functional Classification of Pulmonary Hypertension at 3, 6 and 12 months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months.]
- Change from Baseline in the mean pulmonary artery pressure (mPAP) at 3 and 12 Months. [Time frame: From enrollment to the end of treatment at 3 and12 months]
- Change from Baseline in the Cardiac Index (CI) at 3 and 12 Months. [Time frame: From enrollment to the end of treatment at 3 and12 months]
- Change from Baseline in the Pulmonary Vascular Resistance (PVR) at 3 and 12 Months. [Time frame: From enrollment to the end of treatment at 3 and12 months]
- Change from Baseline in the forced vital capacity (FVC) at 3, 6 and 12 Months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months]
- Change from Baseline in the forced vital capacity of predicted (FVC%pred) at 3, 6 and 12 Months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months]
- Change from Baseline in the forced expiratory volume in 1 second (FEV1) at 3, 6 and 12 Months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months]
- Change from Baseline in the forced expiratory volume in 1 second of predicted (FEV1%pred) at 3, 6 and 12 Months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months]
- Change from Baseline in the FEV1/FVC ratio at 3, 6 and 12 Months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months]
- Change of the BNP/NT-Pro BNP from baseline to the end of treatment at 3, 6 and 12 months. [Time frame: From enrollment to the end of treatment at 3, 6 and 12 months.]
- The restenosis rate of blood vessels after interventional therapy at the end of treatment at 3 and 12 months [Time frame: From enrollment to the end of treatment at 3 and 12 months.]
- Change of the mediastinal lesion volume from baseline to 3 and 12 months after the end of treatment. [Time frame: From enrollment to the end of treatment at 3 and12 months.]
Eligibility criteria
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%.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Chaoyang Hospital, Capital Medical University — Beijing
Publications
- Jia M, Su H, Jiang K, Wang A, Guo Z, Zhu H, Zhang F, Sun X, Shi Y, Pan X, Cao Y. Incidence and predictors of in-stent restenosis following intervention for pulmonary vein stenosis due to fibrosing mediastinitis. Orphanet J Rare Dis. 2024 Oct 14;19(1):379. doi: 10.1186/s13023-024-03391-8. PMID 39397011
- Varghese C, Johnson GB, Eiken PW, Edell ES, Specks U, Larson NB, Peikert T. A Retrospective Evaluation of the Treatment Effects of Rituximab in Patients with Progressive and Symptomatic Fibrosing Mediastinitis. Ann Am Thorac Soc. 2024 Nov;21(11):1533-1541. doi: 10.1513/AnnalsATS.202405-533OC. PMID 39106522
Identifiers
NCT: NCT06980584 · 2025-KE-61_Int