Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Chao Yang Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
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%.
Trial design
Design model
Parallel
Treatments tested in this trial
Rituximab Lymph Node Injection Combined with Pulmonary Vascular Intervention
Procedure/SurgeryBased 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.
Pulmonary Vascular Interventional Therapy
Procedure/SurgeryAccording to the degree of vascular stenosis, individualized and periodic pulmonary vascular interventions are performed to reopen obstructed pulmonary vessels.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Combined treatment groupExperimental treatment 1 intervention
Group B: Interventional-only groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Six Minutes Walk Distance at 12 Months.
Conduct 6-minute walk test to measure the 6-minute walk distance, and compare the walking distances at baseline and 12 months after treatment.
Time frame
From enrollment to the end of treatment at 12 months2
The incidence of treatment-related serious adverse events (SAE)
The incidence of treatment-related serious adverse events is measured by tracking and documenting any SAEs that occur during the treatment period, as well as through follow-up assessments. Each event is evaluated for severity and causality, and the incidence is calculated by dividing the number of patients who experience at least one treatment-related SAE by the total number of treated patients.
Time frame
During the one-year follow-up period after treatment completionSecondary outcomes
1
Change from baseline in the World Health Organization Functional Classification of Pulmonary Hypertension at 3, 6 and 12 months.
Change from Baseline in the World Health Organization Functional Classification of Pulmonary Hypertension (WHO-FC) which assessed based on clinical symptoms and signs at baseline and the end of treatment at 3, 6 and 12 months. The WHO-FC system consists of four levels: I, II, III, and IV. Higher levels indicate progressively more severe conditions.
Time frame
From enrollment to the end of treatment at 3, 6 and 12 months.2
Change from Baseline in the mean pulmonary artery pressure (mPAP) at 3 and 12 Months.
The mean pulmonary artery pressure (mPAP) was measured by right heart catheterization to evaluate the hemodynamic change from baseline to the end of treatment at 3 and12 months.
Time frame
From enrollment to the end of treatment at 3 and12 months3
Change from Baseline in the Cardiac Index (CI) at 3 and 12 Months.
The Cardiac Index (CI) was measured by right heart catheterization to evaluate the hemodynamic change from baseline to the end of treatment at 3 and12 months.
Time frame
From enrollment to the end of treatment at 3 and12 months4
Change from Baseline in the Pulmonary Vascular Resistance (PVR) at 3 and 12 Months.
The Pulmonary Vascular Resistance (PVR) was measured by right heart catheterization to evaluate the hemodynamic change from baseline to the end of treatment at 3 and12 months.
Time frame
From enrollment to the end of treatment at 3 and12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Chao Yang Hospital
Lead sponsor
Beijing Municipal Health Commission
Collaborator
Source ClinicalTrials.gov