NCT06980584Recruiting
Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
Analysis of Clinical Characteristics and Follow-Up Study on Treatment of Nonthrombotic Obstructive Pulmonary Hypertension: Interventional Study
Source: ClinicalTrials.gov · Last updated 23 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 27 Apr 2025
- Start date
- 10 Feb 2025
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Beijing Chao Yang Hospital
- NCT number
- NCT06980584
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 10 Feb 2025 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Currently in the active phase of infection, including but not limited to tuberculosis, Histoplasma capsulatum, and Aspergillus infections;
- The underlying primary disease, such as sarcoidosis, Behcet's disease, or uncontrolled IgG4-related disease, is currently not well controlled.
- Complicated by other end-stage organ dysfunction, such as Child-Pugh class C liver function or stage IV chronic renal failure.
Other
- Before treatment, a large amount of pleural effusion was still present.
- Pulmonary function tests (PFT) showed FEV1 \<30% of the predicted value, FEV1/FVC \<30%, and DLCO \<30%.
- There are contraindications to bronchoscopy or endovascular intervention.
- Complicated by severe immunosuppression.
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.