Multicentre randomized controlled trial of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker withdrawal in advanced renal disease: the STOP-ACEi trial.
Multicentre randomized controlled trial of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker withdrawal in advanced renal disease: the STOP-ACEi trial.
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DOI：
10.1093/ndt/gfv346
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发表时间：
2016-02
期刊：
影响因子：
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通讯作者：
El Nahas M
中科院分区：
文献类型：
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作者：
Bhandari S;Ives N;Brettell EA;Valente M;Cockwell P;Topham PS;Cleland JG;Khwaja A;El Nahas M
使用阻断肾素-血管紧张素醛固酮系统的药物控制血压（BP）和减少尿蛋白排泄是慢性肾脏疾病（CKD）治疗的主要手段。研究已经证实了轻度CKD的益处，但缺乏血管紧张素转换酶抑制剂（ACEi）或血管紧张素受体阻滞剂（ARB）用于晚期CKD的数据。在STOP-ACEi试验中，我们的目的是证实初步结果，即停用ACEi/ARB治疗可以稳定甚至改善晚期进展性CKD患者的肾功能。STOP-ACEi试验（试验注册：当前对照试验，ISRCTN 62869767）是一项由制药商主导的多中心开放标签、随机对照临床试验，纳入了410例接受ACEi、ARB或两者联合治疗的晚期（4期或5期）进展性CKD受试者。患者将以1：1的比例随机分配至停用ACEi、ARB或两者联合治疗（试验组）或继续使用ACEi、ARB或两者联合治疗（对照组）。患者将每3个月随访一次，持续3年。主要结局指标是3年时的eGFR。次要结局指标包括肾脏事件的数量、参与者的生活质量和身体功能、住院率、血压和实验室指标，包括血清胱抑素C。将对安全性进行评估，以确保停用这些治疗不会造成过度伤害或增加死亡率或心血管事件，如心力衰竭、心肌梗死或卒中。此处列出了基本原理和试验设计。本试验的结果将显示停用ACEi/ARB是否可以改善或稳定晚期进展性CKD患者的肾功能。它将显示这种简单的干预是否可以改善实验室和临床结果，包括进展为终末期肾病，而不会导致心血管事件的增加。
Blood pressure (BP) control and reduction of urinary protein excretion using agents that block the renin–angiotensin aldosterone system are the mainstay of therapy for chronic kidney disease (CKD). Research has confirmed the benefits in mild CKD, but data on angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) use in advanced CKD are lacking. In the STOP-ACEi trial, we aim to confirm preliminary findings which suggest that withdrawal of ACEi/ARB treatment can stabilize or even improve renal function in patients with advanced progressive CKD. The STOP-ACEi trial (trial registration: current controlled trials, ISRCTN62869767) is an investigator-led multicentre open-label, randomized controlled clinical trial of 410 participants with advanced (Stage 4 or 5) progressive CKD receiving ACEi, ARBs or both. Patients will be randomized in a 1:1 ratio to either discontinue ACEi, ARB or combination of both (experimental arm) or continue ACEi, ARB or combination of both (control arm). Patients will be followed up at 3 monthly intervals for 3 years. The primary outcome measure is eGFR at 3 years. Secondary outcome measures include the number of renal events, participant quality of life and physical functioning, hospitalization rates, BP and laboratory measures, including serum cystatin-C. Safety will be assessed to ensure that withdrawal of these treatments does not cause excess harm or increase mortality or cardiovascular events such as heart failure, myocardial infarction or stroke. The rationale and trial design are presented here. The results of this trial will show whether discontinuation of ACEi/ARBs can improve or stabilize renal function in patients with advanced progressive CKD. It will show whether this simple intervention can improve laboratory and clinical outcomes, including progression to end-stage renal disease, without causing an increase in cardiovascular events.