Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Beijing Chaoyang Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Juanni Gong, Doctor of Medicine
juannigong2018@126.com
15801511482
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 48
Treatments
Experimental: Combined treatment group
Participants assigned to this group will receive both pulmonary vascular intervention and rituximab lymph node injection.
Active_comparator: Interventional-only group
Participants assigned to this group will receive pulmonary vascular intervention alone.
Sponsors
Collaborators: Beijing Municipal Health Commission
Leads: Beijing Chao Yang Hospital

This content was sourced from clinicaltrials.gov

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