Safety and Efficacy of Balloon Pulmonary Angioplasty in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change of cardiac index (CI) in L/m^2 caused by series of BPA.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
- •Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
- •Not amenable to pulmonary endarterectomy
- •Willing to provide informed consent
排除标准
- •Patients unwilling or unable to provide written consent for participation in the study.
- •Impossible to follow up.
结局指标
主要结局
Change of cardiac index (CI) in L/m^2 caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
Cardiac index (CI) in L/m\^2 is obtained by right cardiac catheterization.
Change of diffusing capacity for carbon monoxide caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
diffusing capacity for carbon monoxide in % is obtained from pulmonary function test
Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
Pulmonary vascular resistance (PVR) in Wood U is obtained by right cardiac catheterization.
Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
World Health Organization is obtained from electronic medical records.
Change of World Health Organization (WHO) functional capacity classification caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
World Health Organization is obtained from electronic medical records.
Incidence of Treatment-Emergent Adverse Events of BPA procedure.
时间窗: From initiation of BPA to 3-12 months after last session
Surveillance of complications including: vessel injury, desaturation, cough, mild hemoptysis (\<50ml), severe hemoptysis (\>50ml), reperfusion pulmonary injury, death.
Change of Pulmonary artery pressure in mmHg caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
Pulmonary artery pressure in mmHg is obtained by right cardiac catheterization.
Change of six minutes walk distance in meter caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
World Health Organization is obtained from electronic medical records.
Change of Peak VO2/kg in ml/min/kg caused by series of BPA.
时间窗: From initiation of BPA to 3-12 months after last session
Peak VO2/kg in ml/min/kg is obtained by cardiopulmonary exercise test.
Change of fibroblast activation protein inhibitor expression after BPA
时间窗: From initiation of BPA to 3-12 months after last session
Change of fibroblast activation protein inhibitor expression after BPA
次要结局
未报告次要终点