End Points for Clinical Trials in Acute Heart Failure Syndromes
End Points for Clinical Trials in Acute Heart Failure Syndromes
复制标题
DOI：
10.1016/j.jacc.2008.12.079
复制
发表时间：
2009-06-16
影响因子：
24
通讯作者：
Felker, G. Michael
中科院分区：
文献类型：
--
作者：
Allen, Larry A.;Hernandez, Adrian F.;Felker, G. Michael
急性心力衰竭综合征（AHFS）仍然是发病率和死亡率的主要原因，部分原因是这些疾病的新疗法的发展已经以频繁失败和很少成功为标志。目前AHFS药物开发方法的异质性，特别是在终点方面，仍然是该领域进展的主要潜在障碍。在最近的AHFS随机临床试验中，涉及血流动力学状态、生物标志物、症状、住院时间、终末器官功能和死亡率的终点均单独或联合使用。在这篇综述中，我们将从临床和统计学的角度讨论各种终点领域，总结已完成和正在进行的AHFS研究中使用的各种终点，并建议在AHFS试验中更标准化终点的步骤。（J Am科尔心脏病学杂志2009; 53：2248-58）（C）美国心脏病学会基金会2009年
Acute heart failure syndromes (AHFS) remain a major cause of morbidity and mortality, in part because the development of new therapies for these disorders has been marked by frequent failure and little success. The heterogeneity of current approaches to AHFS drug development, particularly with regard to end points, remains a major potential barrier to progress in the field. End points involving hemodynamic status, biomarkers, symptoms, hospital stay, end organ function, and mortality have all been employed either alone or in combination in recent randomized clinical trials in AHFS. In this review, we will discuss the various end point domains from both a clinical and a statistical perspective, summarize the wide variety of end points used in completed and ongoing AHFS studies, and suggest steps for greater standardization of end points across AHFS trials. (J Am Coll Cardiol 2009; 53: 2248-58) (C) 2009 by the American College of Cardiology Foundation