Multi-centre Randomized Controlled Trial of angiotensin converting enzyme inhibitor (ACEi) /angiotensin receptor blocker (ARB) - withdrawal in chronic kidney disease – STOP-ACEi-STUDY (SAS)

血管紧张素转换酶抑制剂 (ACEi)/血管紧张素受体阻滞剂 (ARB) 的多中心随机对照试验 - 慢性肾脏病停药 — STOP-ACEi-STUDY (SAS)

• 批准号: MC_PC_14138
• 负责人: Sunil Bhandari
• 金额: $ 31.12万
• 依托单位: Hull & East Yorkshire Hosp (replace)
• 依托单位国家: 英国
• 项目类别: Intramural
• 财政年份: 2014
• 资助国家: 英国
• 起止时间: 2014 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MC_PC_14138
• 关键词: Multi; centre; Randomized; Controlled; Trial

Chronic kidney disease (CKD) affects 1 in 10 adults in the UK and describes progressive loss of function of the kidneys over a period of months or years regardless of the original kidney disease. CKD can have serious implications for those affected including a risk of CKD progressing to complete kidney failure so that the affected person requires replacement of kidney function by dialysis treatment or kidney transplantation. Kidney disease is expensive with a high proportion of the health-care budget spent on people with CKD; the cost of dialysis treatment alone is ~£30,000/year. Patient quality of life can be poor, with dialysis leading to early death. Treating high blood pressure (BP) is the most important intervention that can slow progression of CKD to total kidney failure. Some people with CKD gain additional protection from drugs called Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs). These drugs treat high BP but also slow CKD progression by changing the pressure in the kidney. This may also influence hormone pathways that contribute to the decline of kidney function. However recent research suggests that in some people with advanced CKD (stages 4 & 5) who are progressing to complete kidney failure and are receiving treatment with an ACEi and/ or ARB, stopping these drugs leads to stabilization and improvement of kidney function and decreases or delays the need for dialysis treatment. This indicates that in some patients the very tablets that are being used to protect the kidneys may be contributing to a harmful decline in their function by some currently unknown mechanism. To date, the research on this is observational and to confirm the association between stopping these drugs and stabilization of kidney function requires a study to compare the outcomes of a group of people who have had these drugs stopped with a group who continue on the drug. This is called a randomised controlled trial (RCT). In the STOP-ACEi trial we will randomly allocate suitable participants (by chance) to either continue or to stop their ACEi/ARB treatment and then to follow-up these participants for 3-years. This study is needed before this treatment strategy can be put into routine clinical practice. In addition we will look at other effects of stopping these drugs such as effects on heart attacks, strokes and participant quality of life.

慢性肾脏疾病（CKD）在英国影响十分之一的成年人，并描述了肾脏在几个月或几年内逐渐丧失肾脏的功能。 CKD可能对受影响的患者产生严重影响，包括CKD发生完全肾衰竭的风险，因此受影响的人需要通过透析治疗或肾脏移植来替换肾脏功能。肾脏疾病昂贵，其中CKD患者的医疗保健预算支出很高；仅透析治疗的费用是每年约30,000英镑。患者的生活质量可能很差，透析导致早期死亡。治疗高血压（BP）是最重要的干预措施，可以减缓CKD向总肾脏衰竭的进展。有些患有CKD的人会获得额外的保护，以免被称为血管紧张素转化酶抑制剂（ACEI）或血管紧张素受体阻滞剂（ARB）的药物。这些药物治疗高BP，但也通过改变肾脏的压力来减慢CKD的进展。这也可能影响有助于肾功能下降的骑马途径。然而，最近的研究表明，在某些患有晚期CKD（第4和5阶段）的人中，他们正在逐渐衰竭并接受ACEI和/或ARB接受治疗，阻止这些药物会导致肾脏功能的稳定和改善，并降低或延迟糖尿病治疗。这表明在某些患者中，用于保护肾脏的片剂可能会导致某些目前未知机制的功能有害下降。迄今为止，对此的研究是观察性的，并且要确认停止这些药物与肾脏功能的稳定之间的关联，需要一项研究来比较一群持有这些药物的人的结果与继续使用该药物的一组。这称为随机对照试验（RCT）。在停止ACEI试验中，我们将（偶然）随机分配合适的参与者，以继续或停止其ACEI/ARB治疗，然后跟进这些参与者3年。在将这种治疗策略纳入常规临床实践之前，需要这项研究。此外，我们将研究阻止这些药物的其他影响，例如对心脏病发作，中风和参与生活质量的影响。

项目成果

Multicentre randomized controlled trial of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker withdrawal in advanced renal disease: the STOP-ACEi trial.

• DOI: 10.1093/ndt/gfv346
• 发表时间: 2016-02
• 期刊: Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
• 作者: Bhandari S;Ives N;Brettell EA;Valente M;Cockwell P;Topham PS;Cleland JG;Khwaja A;El Nahas M
• 通讯作者: El Nahas M

Should We STOP Angiotensin Converting Enzyme Inhibitors/Angiotensin Receptor Blockers in Advanced Kidney Disease?

• DOI: 10.1159/000447068
• 发表时间: 2016-01-01
• 期刊: NEPHRON
• 影响因子: 2.5
• 作者: Ahmed, Aimun;Jorna, Tom;Bhandari, Sunil
• 通讯作者: Bhandari, Sunil

How Do We Navigate the Complexities Surrounding the Use of Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers in Chronic Kidney Disease?

• DOI: 10.1016/j.mayocp.2019.09.014
• 发表时间: 2019-11-01
• 期刊: MAYO CLINIC PROCEEDINGS
• 影响因子: 8.9
• 作者: Chadburn, Sunil Bhandari;Chadburn, Marie
• 通讯作者: Chadburn, Marie

In reply: Is diabetes still a compelling indication for renin-angiotensin-aldosterone system inhibitors?

回复：糖尿病仍然是肾素-血管紧张素-醛固酮系统抑制剂的一个令人信服的适应症吗？

• DOI: 10.3949/ccjm.87c.01002
• 发表时间: 2020
• 期刊: Cleveland Clinic journal of medicine
• 影响因子: 6.1
• 作者: Bhandari S

Withdrawal of renin-angiotensin system inhibitors' effect on estimated glomerular filtration rate in adults with advanced kidney disease: the STOP-ACEi RCT

停用肾素-血管紧张素系统抑制剂对晚期肾病成人估计肾小球滤过率的影响：STOP-ACEi RCT

• DOI: 10.3310/ttmc6210
• 发表时间: 2024
• 期刊: Efficacy and Mechanism Evaluation
• 作者: Bhandari S