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_戚文威.pdf

中国循环杂志 2015 年 3 月 第 30 卷 第 3 期（总第 201 期）Chinese Circulation Journal，March，2015，Vol. 30 No.3（Serial No.201） 251 临床研究 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 * 戚文威，刘彤，许纲，李立丰，梁英姿，叶岚，李广平 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 1 879 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。 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 Upstream Therapeutic Strategies of Valsartan and Fluvastatin in Treating the Patients With Hypertension Combining Atrial Fibrillation QI Wen-wei, LIU Tong, XU Gang, LI Li-feng, LIANG Ying-zi, YE Lan, LI Guang-ping. Department of Cardiology, The Second Hospital of Tianjin Medical University, Tianjin (300211), China Corresponding Author: LI Guang-ping, E-mail: tjcardiol@ Abstract Objective: To investigate weather valsartan and/or fluvastatin 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, four- arm 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 (MI), heart failure (NYHA III or IV ), cardiac shock, severe bl