Study on the Treatment of Nonthrombotic Obstructive Pulmonary Hypertension

Not Applicable

Recruiting

• Conditions: Fibrosing Mediastinitis; Pulmonary Hypertension

• Registration Number: NCT06980584
• Lead Sponsor: Beijing Chao Yang Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-10
• Study First Submitted: 2025-04-27
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-10-31
• Study Completion: 2027-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Six Minutes Walk Distance at 12 Months.	From enrollment to the end of treatment 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.
The incidence of treatment-related serious adverse events (SAE)	During the one-year follow-up period after treatment completion	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the World Health Organization Functional Classification of Pulmonary Hypertension at 3, 6 and 12 months.	From enrollment to the end of treatment 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.
Change from Baseline in the mean pulmonary artery pressure (mPAP) at 3 and 12 Months.	From enrollment to the end of treatment at 3 and12 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.
Change from Baseline in the Cardiac Index (CI) at 3 and 12 Months.	From enrollment to the end of treatment at 3 and12 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.
Change from Baseline in the Pulmonary Vascular Resistance (PVR) at 3 and 12 Months.	From enrollment to the end of treatment at 3 and12 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.
Change from Baseline in the forced vital capacity (FVC) at 3, 6 and 12 Months.	From enrollment to the end of treatment at 3, 6 and 12 months	Pulmonary function tests was performed, including the forced vital capacity (FVC), to evaluated pulmonary function at baseline and the end of treatment at 3, 6 and 12 Months.
Change from Baseline in the forced vital capacity of predicted (FVC%pred) at 3, 6 and 12 Months.	From enrollment to the end of treatment at 3, 6 and 12 months	Pulmonary function tests was performed, including the forced vital capacity of predicted (FVC%pred), to evaluated pulmonary function at baseline and the end of treatment at 3, 6 and 12 Months.
Change from Baseline in the forced expiratory volume in 1 second (FEV1) at 3, 6 and 12 Months.	From enrollment to the end of treatment at 3, 6 and 12 months	Pulmonary function tests was performed, including the forced expiratory volume in 1 second (FEV1), to evaluated ventilation function at baseline and the end of treatment at 3, 6 and 12 Months.
Change from Baseline in the forced expiratory volume in 1 second of predicted (FEV1%pred) at 3, 6 and 12 Months.	From enrollment to the end of treatment at 3, 6 and 12 months	Pulmonary function tests was performed, including the forced expiratory volume in 1 second of predicted (FEV1%pred), to evaluated ventilation function at baseline and the end of treatment at 3, 6 and 12 Months.
Change from Baseline in the FEV1/FVC ratio at 3, 6 and 12 Months.	From enrollment to the end of treatment at 3, 6 and 12 months	Pulmonary function tests was performed, including the FEV1/FVC ratio, to evaluated ventilation function at baseline and the end of treatment at 3, 6 and 12 Months.
Change of the BNP/NT-Pro BNP from baseline to the end of treatment at 3, 6 and 12 months.	From enrollment to the end of treatment at 3, 6 and 12 months.	The BNP/NT-Pro BNP will be measured at baseline the end of treatment at 3, 6 and 12 months to evaluate the condition of heart failure.
The restenosis rate of blood vessels after interventional therapy at the end of treatment at 3 and 12 months	From enrollment to the end of treatment at 3 and 12 months.	Restenosis following interventional therapy was monitored at the end of treatment at 3 and 12 months, with restenosis defined as a blood vessel diameter reduction of more than 50% from the original size, or when the pressure gradient (Pd) at the site of vascular stenosis increases by 5 mmHg or more compared to the last measurement.
Change from baseline of the quality-of-life score at 3, 6 and 12 months after the end of treatment.	From enrollment to the end of treatment at 3, 6 and 12 months	Quality of life was assessed using the 36-Item Short-Form Health Survey (SF-36) at baseline and 3, 6 and 12 months after the end of treatment. The SF-36 scoring scale consists of 8 dimensions, which can be summarized as physical health and mental health. The score range of each dimension is 0 to 100 points. The higher the score, the better the health condition.
Number of participants with complications of bronchoscopy and pulmonary intervention.	Immediately or in the short term after treatment, and within 12 months after treatment	Measure the probability of complications occurring during or after therapeutic operations. Complications of pulmonary vascular intervention include pulmonary vascular injury, arrhythmia, reperfusion pulmonary edema, etc; Complications of bronchoscopy include pneumothorax, massive hemoptysis, infection, etc.
Change of the mediastinal lesion volume from baseline to 3 and 12 months after the end of treatment.	From enrollment to the end of treatment at 3 and12 months.	The mediastinal lesion volume will be measured at baseline and 3, 12 months after the end of treatment using CTPA or PET-CT imaging. The volume is represented by the maximum transverse diameter of the cross-section of the lesion site.

Trial Locations

Locations (1)

Beijing Chaoyang Hospital, Capital Medical University; 🇨🇳 Beijing, China