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Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH).
The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.
This study is a prospective, multi-center, long-term observational project to study the safety and efficacy of BPA. Clinical evaluation, including: functional capacity, 6-minutes walking test, biomarkers, cardiopulmonary exercise test, electrocardiography, echocardiography, haemodynamics, pulmonary angiography and lung scintigraphy was performed before the initiation therapy of BPA, and 3-12 months after last session of BPA.
we also aim to evaluate the value of FAPI in predicting the efficacy and the prognosis of patients with CTEPH who received BPA.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon pulmonary angioplasty | Procedure | Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events of BPA procedure. | Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (<50ml), severe hemoptysis (>50ml), reperfusion pulmonary injury, death. | From initiation of BPA to 3-12 months after last session |
| Change of Pulmonary artery pressure in mmHg caused by series of BPA. | Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization. | From initiation of BPA to 3-12 months after last session |
| Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA. | Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization. | From initiation of BPA to 3-12 months after last session |
| Change of cardiac index (CI) in L/m^2 caused by series of BPA. | Cardiac index (CI) in L/m^2 is obtained by right cardiac catheterization. | From initiation of BPA to 3-12 months after last session |
| Change of World Health Organization (WHO) functional capacity classification caused by series of BPA. | World Health Organization is obtained from electronic medical records. | From initiation of BPA to 3-12 months after last session |
| Change of six minutes walk distance in meter caused by series of BPA. | World Health Organization is obtained from electronic medical records. | From initiation of BPA to 3-12 months after last session |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic thromboembolic pulmonary hypertension patients admitted in hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Liu, doctor | Contact | 86-010-88396589 | zhihongliufuwai@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| center of pulmonary vascular disease, Fuwai hospital | Recruiting | Beijing | 100037 | China |
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| Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA. | World Health Organization is obtained from electronic medical records. | From initiation of BPA to 3-12 months after last session |
| Change of Peak VO2/kg in ml/min/kg caused by series of BPA. | Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test. | From initiation of BPA to 3-12 months after last session |
| Change of diffusing capacity for carbon monoxide caused by series of BPA. | diffusing capacity for carbon monoxide in % is obtained from pulmonary function test | From initiation of BPA to 3-12 months after last session |
| Change of fibroblast activation protein inhibitor expression after BPA | Change of fibroblast activation protein inhibitor expression after BPA | From initiation of BPA to 3-12 months after last session |
| Chinese Academy of Medical Sciences Fuwai hospital | Recruiting | Beijing | 100037 | China |
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