PDF(Pubmed)
Abstract：
BACKGROUND: Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive pulmonary vascular disorder with substantial morbidity and mortality, also a disease underdiagnosed and undertreated. It is potentially curable by pulmonary endarterectomy (PEA) in patients with surgically accessible thrombi. Balloon pulmonary angioplasty (BPA) and targeted medical therapy are options for patients with distal lesions or persistent/recurrent pulmonary hypertension after PEA. There is an urgent need to increase the awareness of CTEPH. Qualified CTEPH centers are still quite limited. Baseline characteristics, management pattern and clinical outcome of CTEPH in China needs to be reported.
METHODS: The CHinese reAl-world study to iNvestigate the manaGEment pattern and outcomes of chronic thromboembolic pulmonary hypertension (CHANGE) study is designed to provide the multimodality treatment pattern and clinical outcomes of CTEPH in China. Consecutive patients who are ≥ 14 year-old and diagnosed with CTEPH are enrolled. The diagnosis of CTEPH is confirmed in right heart catheterization and imaging examinations. The multimodality therapeutic strategy, which consists of PEA, BPA and targeted medical therapy, is made by a multidisciplinary team. The blood sample and tissue from PEA are stored in the central biobank for further research. The patients receive regular follow-up every 3 or 6 months for at least 3 years. The primary outcomes include all-cause mortality and changes in functional and hemodynamic parameters from baseline. The secondary outcomes include the proportion of patients experiencing lung transplantation, the proportion of patients experiencing heart and lung transplantation, and changes in health-related quality of life. Up to 31 December 2023, the study has enrolled 1500 eligible patients from 18 expert centers.
CONCLUSIONS: As a real-world study, the CHANGE study is expected to increase our understanding of CTEPH, and to fill the gap between guidelines and the clinical practice in the diagnosis, assessment and treatment of patients with CTEPH. REGISTRATION NUMBER IN CLINICALTRIALS.GOV: NCT05311072.
METHODS: The CHinese reAl-world study to iNvestigate the manaGEment pattern and outcomes of chronic thromboembolic pulmonary hypertension (CHANGE) study is designed to provide the multimodality treatment pattern and clinical outcomes of CTEPH in China. Consecutive patients who are ≥ 14 year-old and diagnosed with CTEPH are enrolled. The diagnosis of CTEPH is confirmed in right heart catheterization and imaging examinations. The multimodality therapeutic strategy, which consists of PEA, BPA and targeted medical therapy, is made by a multidisciplinary team. The blood sample and tissue from PEA are stored in the central biobank for further research. The patients receive regular follow-up every 3 or 6 months for at least 3 years. The primary outcomes include all-cause mortality and changes in functional and hemodynamic parameters from baseline. The secondary outcomes include the proportion of patients experiencing lung transplantation, the proportion of patients experiencing heart and lung transplantation, and changes in health-related quality of life. Up to 31 December 2023, the study has enrolled 1500 eligible patients from 18 expert centers.
CONCLUSIONS: As a real-world study, the CHANGE study is expected to increase our understanding of CTEPH, and to fill the gap between guidelines and the clinical practice in the diagnosis, assessment and treatment of patients with CTEPH. REGISTRATION NUMBER IN CLINICALTRIALS.GOV: NCT05311072.
摘要：
背景：慢性血栓栓塞性肺动脉高压（CTEPH）是一种进行性肺血管疾病，具有相当高的发病率和死亡率，也是一种未被诊断和治疗不足的疾病。对于手术可接近的血栓患者，通过肺内膜切除术（PEA）可以治愈。球囊肺血管成形术（BPA）和靶向药物治疗是PEA后远端病变或持续性/复发性肺动脉高压患者的选择。迫切需要提高对CTEPH的认识。合格的CTEPH中心仍然相当有限。基线特征，中国CTEPH的管理模式和临床结局需要报告。
方法：中国reAl-world研究慢性血栓栓塞性肺动脉高压（CHANGE）的治疗模式和结果旨在提供中国CTEPH的多模式治疗模式和临床结果。连续招募≥14岁并诊断为CTEPH的患者。在右心导管插入术和影像学检查中证实了CTEPH的诊断。多模态治疗策略，由PEA组成，BPA和靶向药物治疗，是由一个多学科的团队。来自PEA的血液样品和组织储存在中央生物库中用于进一步研究。患者每3或6个月接受定期随访，至少3年。主要结果包括全因死亡率和功能和血液动力学参数相对于基线的变化。次要结果包括接受肺移植的患者比例，接受心肺移植的患者比例，以及与健康相关的生活质量的变化。截至2023年12月31日，该研究已从18个专家中心招募了1500名符合条件的患者。
结论：作为一项真实世界的研究，CHANGE研究有望增加我们对CTEPH的理解，填补诊断指南和临床实践之间的空白，CTEPH患者的评估和治疗。临床试验中的登记号。GOV：NCT05311072。
方法：中国reAl-world研究慢性血栓栓塞性肺动脉高压（CHANGE）的治疗模式和结果旨在提供中国CTEPH的多模式治疗模式和临床结果。连续招募≥14岁并诊断为CTEPH的患者。在右心导管插入术和影像学检查中证实了CTEPH的诊断。多模态治疗策略，由PEA组成，BPA和靶向药物治疗，是由一个多学科的团队。来自PEA的血液样品和组织储存在中央生物库中用于进一步研究。患者每3或6个月接受定期随访，至少3年。主要结果包括全因死亡率和功能和血液动力学参数相对于基线的变化。次要结果包括接受肺移植的患者比例，接受心肺移植的患者比例，以及与健康相关的生活质量的变化。截至2023年12月31日，该研究已从18个专家中心招募了1500名符合条件的患者。
结论：作为一项真实世界的研究，CHANGE研究有望增加我们对CTEPH的理解，填补诊断指南和临床实践之间的空白，CTEPH患者的评估和治疗。临床试验中的登记号。GOV：NCT05311072。
