缬沙坦与氟伐他汀对高血压合并心房颤动上游防治策略的研究设计  

Upstream Therapeutic Strategies of Valsartan and Fluvastatin in Treating the Patients With Hypertension Combining Atrial Fibrillation

作　　者：戚文威[1] 刘彤[1] 许纲[1] 李立丰[1] 梁英姿[1] 叶岚[1] 李广平[1] 

机构地区：[1]天津市心血管病离子与分子机能重点实验室天津心脏病学研究所天津医科大学第二医院心脏科,300211

出　　处：《中国循环杂志》2015年第3期251-255,共5页Chinese Circulation Journal

基　　金：天津市科技计划项目(13ZCZDSY01400)

摘　　要：目的：探讨缬沙坦和（或）氟伐他汀是否可以降低高血压合并非永久性心房颤动（房颤）患者的房颤复发率，延缓非永久性房颤进展为永久性房颤。方法：该研究是一项在高血压合并非永久性房颤患者中评估缬沙坦和氟伐他汀上游防治效果的多中心、随机、开放、四组平行设计的研究，其首要评价终点为观察期间阵发性房颤进展为持续性房颤、非永久性房颤进展为永久性房颤的发生率。次要评价终点为：心肌梗死、Ⅲ～Ⅳ级的心力衰竭、心源性休克、需要住院的严重出血、室性恶性心律失常、血运重建治疗、射频消融治疗、脑卒中、心原性死亡、全因死亡和房颤复发率等。本研究将在全国15个医疗中心随访1879例高血压合并非永久性房颤患者。结论：本研究首次在我国高血压合并非永久性房颤患者中评估缬沙坦和（或）氟伐他汀对非永久性房颤效果，将为房颤上游综合防治策略提供依据。Objective： To investigate weather valsartan and/or lfuvastatin may reduce the recurrence rate of non-permanent atrial fibrillation （AF） in patients with hypertension, and to prolong the prognosis time from non-permanent AF to permanent AF. Methods： Our research has been named as VF-HT-AF study, which is a multicenter, randomized, open-label, fourarm parallel group study with the comparative evaluation of valsartan and fluvastatin as upstream treatment in patients with hypertension combining non-permanent AF. The primary endpoints are to study the prognosis rate from paroxysmal AF to persistent AF, and to study the prognosis rate from non-permanent AF to permanent AF during the observation period. The secondary endpoints include： myocardial infarction （M1）, heart failure （NYHA III or IV ）, cardiac shock, severe bleeding which needs admission, malignant ventrieular arrhythmia, revascularization therapy （CABG/PCI）, radiofrequency catheter ablation of AF, stroke, cardiac death, all cause mortality and AF recurrence. A total of 1879 patients will be investigated from 15 medical centers nationwide to obtain the relevant information. Conclusion： This is the first clinical trial for evaluating the impact of valsartan and/or fluvastatin in treating thepatients with hypertension combining non-permanent AF in China, it will provide the upstream therapeutic experience for clinical practice.

关 键 词：心房颤动 氟伐他汀 缬沙坦 7天动态心电监测 随机对照临床试验 

分 类 号：R54[医药卫生—心血管疾病]