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Analysis of Echocardiographic Outcome Measures in Randomized Controlled Trials in Heart Failure with Preserved Ejection Fraction

  

  1. 1.Cardiovascular Department,Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China;2.Graduate School,China Academy of Chinese Medical Sciences,Beijing 100007,China;3.National Clinical Research Center for Cardiovascular Diseases of Traditional Chinese Medicine,Beijing 100091,China
  • Received:2024-08-14 Revised:2024-10-10 Accepted:2024-10-14
  • Contact: DONG Guoju,Chief physician/Doctoral supervisor;E-mail:13691393589@163.com

射血分数保留型心力衰竭随机对照试验的超声心动图结局指标研究

  

  1. 1.100091 北京市,中国中医科学院西苑医院心血管科;2.100007 北京市,中国中医科学院研究生院;3.100091 北京市,国家中医心血管病临床医学研究中心
  • 通讯作者: 董国菊,主任医师/博士生导师;E-mail:13691393589@163.com
  • 基金资助:
    国家自然科学基金资助项目(82074423);中国中医科学院科技创新重大攻关项目(CI2021A00903);中国中医科学院西苑医院能力提升项目(XYZX0201-02);中国中医科学院科技创新工程医理交叉课题(CI2023C010YL)

Abstract: Background The selection of echocardiographic indexes for efficacy evaluation of heart failure with preserved ejection fraction(HFpEF)lacks a uniform standard. Objective Analyze the echocardiographic outcome measures in randomized controlled trials(RCT)of HFpEF to provide a reference for the development of a standardized efficacy evaluation system for HFpEF. Methods PubMed,Embase and Cochrane Central Register of Controlled Trials were searched for RCT related to HFpEF from January 1,2021 to November 3,2023. Echocardiographic outcome measures and other information were extracted after literature screening according to eligibility criteria. The frequency and percentage of echocardiographic outcome measures were analyzed and an association rule analysis was conducted. Results A total of 825 literatures were obtained and 14 literatures were finally included after screening. A total of 39 echocardiographic outcome measures were used in 14 studies. The minimum number of echocardiographic outcome measures used in a single study was 2,and the maximum was 18. The top 10 echocardiographic outcome measures in terms of usage frequency were ratio of mitral peak velocity of early filling(E)to mitral peak velocity of late filling(A),left ventricular ejection fraction(LVEF),average ratio of E to early diastolic mitral annular velocity(e'),left atrial volume index(LAVI),left ventricular end-diastolic diameter(LVEDD),left atrial diameter(LAD),septal E/e',left ventricular mass index(LVMI),E deceleration time(EDT)and tricuspid annular plane systolic excursion(TAPSE). The association rule analysis showed that when different quantitative indicators were combined,the rules with the highest support were respectively average E/e' → LAVI,LVEF+E/A → LVEDD and LAVI+average E/e'+LVEF → LVEDD. Conclusion In HFpEF RCTs,the commonly used echocardiographic outcome measures are E/A,LVEF,and average E/e'. Moreover,LAVI and LVEDD are often used in combination with the above indicators. Lack of consistency,rationality,recognition and standardization are the problems of echocardiographic outcome measures selection in HFpEF RCTs. The development of a core outcome set may be an effective way to solve the above problems.

Key words: Heart Failure, Heart failure with preserved ejection fraction, Randomized controlled trial, Clinical research, Echocardiography, Outcome measure

摘要: 背景 射血分数保留型心力衰竭(HFpEF)超声心动图疗效评价指标的选择缺乏统一标准。目的 分析HFpEF随机对照试验(RCT)中的超声心动图结局指标,为HFpEF标准化疗效评价体系的构建提供参考。方法 检索PubMed、Embase和Cochrane Central Register of Controlled Trials数据库中与HFpEF相关的RCT,时间为2021-01-01—2023-11-03。根据纳入、排除标准筛选文献后提取超声心动图结局指标等信息。统计超声心动图结局指标的频次、频率并进行关联规则分析。结果 共检索到825篇文献,经筛选最终纳入14篇文献。14篇文献共使用39个超声心动图结局指标,单项研究最少使用2个,最多使用18个。使用频次排名前10的指标为左房室瓣舒张早期血流速度峰值(E)/舒张晚期血流速度峰值(A)、左心室射血分数(LVEF)、平均E/舒张早期左房室瓣环组织运动速度峰值(e')、左心房容积指数(LAVI)、左心室舒张末期内径(LVEDD)、左心房内径(LAD)、间隔E/e'、左心室质量指数(LVMI)、E峰减速时间(EDT)、右房室瓣环收缩期位移(TAPSE)。关联规则分析显示,不同数量指标组合时条件支持度最高的规则分别为平均E/e'→LAVI、LVEF+E/A→LVEDD、LAVI+平均E/e'+LVEF→LVEDD。结论 HFpEF RCTs中常用的超声心动图结局指标有E/A、LVEF和平均E/e',LAVI、LVEDD常与以上指标组合使用。HFpEF RCTs中超声心动图结局指标的选择存在不一致、不合理、不公认、不规范的问题,建立核心指标集可能是解决上述问题的有效方法。

关键词: 心力衰竭, 射血分数保留型心力衰竭, 随机对照试验, 临床研究, 超声心动描记术, 结局指标

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