Division of Cardiovascular Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom; Manchester University NHS Foundation Trust, Wythenshawe, Manchester, United Kingdom.
Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom.
JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 2):2319-2331. doi: 10.1016/j.jcmg.2019.03.034. Epub 2019 Aug 14.
The myocardial interstitium has emerged as a potential therapeutic target and as a biological entity to improve risk stratification and better guide existing interventions. Clinical trials focusing on the myocardial interstitium are required to establish causality and improve patient outcomes. This review will discuss issues around clinical trials targeting the myocardial interstitium, including antifibrotic therapies, efficacy outcome measurements, mechanistic outcome measurements and mediation analysis, sample size, trial duration, considerations for multicenter trials, stratifying trial recruitment according to the interstitium, and approaches to enrich recruitment, using examples of ongoing clinical trials.
心肌间质已成为一个有潜力的治疗靶点和生物学实体，可以改善风险分层，更好地指导现有干预措施。需要进行针对心肌间质的临床试验来确定因果关系并改善患者的结局。本综述将讨论针对心肌间质的临床试验中的问题，包括抗纤维化治疗、疗效终点测量、机制终点测量和中介分析、样本量、试验持续时间、多中心试验的考虑因素、根据间质分层试验招募以及丰富招募途径的方法，同时还将举例介绍正在进行的临床试验。
