Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension (ACCT-NOPH)

Capital Medical University

Status: Enrolling

Conditions: Fibrosing Mediastinitis; Pulmonary Hypertension

Treatments: Procedure: Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention; Procedure: Pulmonary Vascular Interventional Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06980584

2025-KE-61_Int

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Combined treatment group

Experimental group

Description:

Participants assigned to this group will receive both pulmonary vascular intervention and rituximab lymph node injection.

Treatment:

Procedure: Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention

Interventional-only group

Active Comparator group

Description:

Participants assigned to this group will receive pulmonary vascular intervention alone.

Treatment:

Procedure: Pulmonary Vascular Interventional Therapy