Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
NCT06980584

Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

Led by Beijing Chao Yang Hospital · Updated on 2025-05-23

48

Participants Needed

1

Research Sites

141 weeks

Total Duration

On this page

Sponsors

B

Beijing Chao Yang Hospital

Lead Sponsor

B

Beijing Municipal Health Commission

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with fibrosing mediastinitis between November 2024 and November 2026, aged between 18 and 85 years
  • Symptoms include chest tightness, shortness of breath, and reduced exercise tolerance
  • Chest CT shows mediastinal lymph node compression of the pulmonary artery with pulmonary hypertension consistent with symptoms
  • Signed informed consent and able to comply with study protocol and one-year follow-up
Not Eligible

You will not qualify if you...

  • Active infections including tuberculosis, Histoplasma capsulatum, or Aspergillus
  • Uncontrolled primary diseases such as sarcoidosis, Behcet's disease, or IgG4-related disease
  • Presence of large pleural effusion before treatment
  • Pulmonary function tests showing FEV1 <30% predicted, FEV1/FVC <30%, or DLCO <30%
  • Contraindications to bronchoscopy or endovascular intervention
  • End-stage organ dysfunction like Child-Pugh class C liver disease or stage IV chronic renal failure
  • Severe immunosuppression

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Actively Recruiting

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Research Team

J

Juanni Gong, Doctor of Medicine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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