Treatment for Nonthrombotic Obstructive Pulmonary Hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and safety of rituximab lymph node injection combined with pulmonary vascular intervention in patients with fibrosing mediastinal pulmonary hypertension. Participants are randomly assigned to receive either the combined treatment or pulmonary vascular intervention alone. The study assesses outcomes such as symptom improvement, hemodynamic changes, and lesion volume reduction at 3, 6, and 12 months post-treatment. Safety is evaluated by comparing the incidence of adverse events between the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Juanni Gong, Doctor of Medicine
• Email: juannigong2018@126.com
• Phone: 15801511482

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.