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Observational and therapeutic studies on nonthrombotic obstructive pulmonary hypertension

Analysis of clinical characteristics and follow-up study on treatment of nonthrombotic obstructive pulmonary hypertention

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112867
Enrollment
Unknown
Registered
2025-11-20
Start date
2025-02-24
Completion date
Unknown
Last updated
2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic thromboembolic pulmonary hypertension

Interventions

Combined treatment group:Tracheoscopic rituximab lymph node injection combined with pulmonary vascular intervention
Intervention alone group:Pulmonary vascular intervention

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Observational study: Patients with CTEPH, TA-PH and FM-PH diagnosed in our hospital from January 1, 2011 to November 2026; Therapeutic research: 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

Exclusion criteria: Observational study: Patients without complete clinical, imaging, and right heart floating catheter data; Therapeutic research: 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, Behçet’s disease, or uncontrolled IgG4-related disease, is currently not well controlled; 3. There was still a large amount of pleural effusion before the treatment; 4. There are contraindications to bronchoscopy or endovascular intervention; 5. Pulmonary function tests showed FEV1 <30% of the predicted value, FEV1/FVC <30%, and DLCO <30%; 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.

Design outcomes

Primary

MeasureTime frame
Improvement of symptoms and signs;Changes in WHO functional class;Hemodynamic changes;BNP/NT-proBNP levels;6-minute walk distance (6MWD);Changes in pulmonary function;Post-interventional restenosis rate (greater than 50% of the original vessel diameter);Incidence of treatment-related serious adverse events (SAE);

Secondary

MeasureTime frame
Quality of Life score;Changes in cardiac ultrasound parameters;The volume of mediastinal lesions;Clinical deterioration rate (re-hospitalization rate due to right heart failure);Abnormal laboratory or physiological indicators;Complications of bronchoscopy operation and pulmonary vascular interventional therapy;

Countries

China

Contacts

Public ContactJuanni Gong

Beijing Chao-Yang Hospital, Capital Medical University

15801511482@126.com+86 10 52011619

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026