Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

NCT ID: NCT06980584

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-10
• Study Completion Date: 2027-10-31

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.

Conditions

Fibrosing Mediastinitis; Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combined treatment group

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

Group Type: EXPERIMENTAL

Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention

Intervention Type: PROCEDURE

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.

Interventional-only group

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

Group Type: ACTIVE_COMPARATOR

Pulmonary Vascular Interventional Therapy

Intervention Type: PROCEDURE

According to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Health Commission

OTHER_GOV

Sponsor Role: collaborator

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Chaoyang Hospital, Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Juanni Gong, Doctor of Medicine

Role: CONTACT

juannigong2018@126.com

15801511482

Facility Contacts

Juanni Gong

Role: primary

juannigong2018@126.com

15801511482

References

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.

Reference Type: BACKGROUND

PMID: 39397011 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39106522 (View on PubMed)

Other Identifiers

2025-KE-61_Int

Identifier Type: -

Identifier Source: org_study_id