Natriuretic Peptides, 6-Min Walk Test, and Quality-of-Life Questionnaires as Clinically Meaningful Endpoints in HF Trials

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• 作者：Joã ; o Pedro Ferreira ; MD ; PhD^a ; Kevin Duarte ; Msc^a ; Todd L. Graves ; PhD^b ; Michael R. Zile ; MD^c ; William T. Abraham ; MD^d ; Fred A. Weaver ; MD^e ; JoAnn Lindenfeld ; MD^f ; Faiez Zannad ; MD ; PhD^a ; ^{f.zannad@chru-nancy.fr}
• 关键词：heart failure trials ; natriuretic peptides ; surrogate endpoints
• 刊名：Journal of the American College of Cardiology
• 出版年：2016
• 出版时间：20 December 2016
• 年：2016
• 卷：68
• 期：24
• 页码：2690-2707
• 全文大小：582 K
• 卷排序：68

文摘

The Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions document was issued as a guidance for industry and for the Food and Drug Administration. The Expedited Access Pathway was designed as a new program for medical devices that demonstrated the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. The Food and Drug Administration would consider assessments of a device’s effect on intermediate endpoints that, when improving in a congruent fashion, are reasonably likely to predict clinical benefit. The purpose of this review is to provide evidence to support the use of 3 such intermediate endpoints: natriuretic peptides, such as N-terminal pro–B-type natriuretic peptide/B-type natriuretic peptide, the 6-min walk test distance, and health-related quality of life in heart failure.