Selvanayagam Joseph B, Hartshorne Trent, Billot Laurent, Grover Suchi, Hillis Graham S, Jung Werner, Krum Henry, Prasad Sanjay, McGavigan Andrew D
Department of Cardiovascular Medicine, Flinders Medical Centre, Adelaide, SA, Australia.
School of Medicine, Flinders University, Adelaide, SA, Australia.
Ann Noninvasive Electrocardiol. 2017 Jul;22(4). doi: 10.1111/anec.12420. Epub 2017 Jan 24.
The majority of sudden cardiac death (SCD) in patients with heart failure occurs in those with mild-moderate left ventricular (LV) systolic dysfunction (LVEF 36-50%) who under current guidelines are ineligible for primary prevention implantable cardiac defibrillator (ICD) therapy. Recent data suggest that cardiac magnetic resonance (CMR) evidence of replacement fibrosis forms a substrate for malignant arrhythmia and therefore potentially identifies a subgroup at increased risk of SCD. Our hypothesis is that among patients with mild-moderate LV systolic dysfunction, a CMR-guided management strategy for ICD insertion based on the presence of scar or fibrosis is superior to a current strategy of standard care.
METHODS/DESIGN: CMR GUIDE is a prospective, multicenter randomized control trial enrolling patients with mild-moderate LV systolic dysfunction and CMR evidence of fibrosis on optimal heart failure therapy. Participants will be randomized to receive either a primary prevention ICD or an implantable loop recorder (ILR). The primary endpoint is the time to SCD or hemodynamically significant ventricular arrhythmia (VF or VT) during an average 4-year follow-up. Secondary endpoints include quality of life assessed by Minnesota Living with Heart Failure Questionnaire, heart failure related hospitalizations, and a cost-utility analysis. Clinical trials.gov identifier NCT01918215.
CMR GUIDE trial will add substantially to our understanding of the role of myocardial fibrosis and the risk of developing life-threatening ventricular arrhythmias. If the superiority of a CMR-guided approach over standard care is proven, it may change international clinical guidelines, with the potential to considerably increase survival in this growing patient population.
心力衰竭患者的大多数心源性猝死（SCD）发生在左心室（LV）收缩功能轻度至中度障碍（左室射血分数36 - 50%）的患者中，根据现行指南，这些患者不符合一级预防植入式心脏除颤器（ICD）治疗的条件。近期数据表明，心脏磁共振成像（CMR）显示的替代性纤维化是恶性心律失常的基础，因此可能识别出SCD风险增加的亚组。我们的假设是，在轻度至中度LV收缩功能障碍的患者中，基于瘢痕或纤维化的存在采用CMR指导的ICD植入管理策略优于当前的标准治疗策略。
方法/设计：CMR GUIDE是一项前瞻性、多中心随机对照试验，纳入轻度至中度LV收缩功能障碍且在最佳心力衰竭治疗下有CMR纤维化证据的患者。参与者将被随机分配接受一级预防ICD或植入式环路记录器（ILR）。主要终点是平均4年随访期间发生SCD或血流动力学显著的室性心律失常（室颤或室速）的时间。次要终点包括通过明尼苏达心力衰竭生活问卷评估的生活质量、与心力衰竭相关的住院情况以及成本效益分析。ClinicalTrials.gov标识符：NCT01918215。
CMR GUIDE试验将极大地增进我们对心肌纤维化作用以及发生危及生命的室性心律失常风险的理解。如果CMR指导的方法优于标准治疗得到证实，可能会改变国际临床指南，有可能显著提高这一不断增长的患者群体的生存率。
