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

慢性肾脏疾病（CKD）影响英国十分之一的成年人，描述的是肾脏功能在数月或数年内逐渐丧失，与最初的肾脏疾病无关。CKD可能对患者产生严重影响，包括CKD进展为完全肾功能衰竭的风险，因此患者需要通过透析治疗或肾移植来替代肾功能。肾病费用昂贵，在慢性肾病患者身上花费的医疗预算比例很高；仅透析治疗的费用每年约为3万英镑。患者的生活质量可能很差，透析会导致早期死亡。治疗高血压（BP）是最重要的干预措施，可以减缓CKD进展到完全肾衰竭。一些CKD患者从血管紧张素转换酶抑制剂（ACEi）或血管紧张素受体阻滞剂（ARBs）药物中获得额外的保护。这些药物治疗高血压，但也通过改变肾脏压力来减缓CKD的进展。这也可能影响导致肾功能下降的激素通路。然而，最近的研究表明，在一些晚期CKD（4期和5期）患者进展为完全肾功能衰竭并正在接受ACEi和/或ARB治疗时，停用这些药物可导致肾功能稳定和改善，并减少或延迟透析治疗的需要。这表明，在一些患者中，用于保护肾脏的药片可能会以某种目前未知的机制导致肾脏功能的有害下降。迄今为止，这方面的研究都是观察性的，为了证实停药与肾功能稳定之间的联系，需要一项研究来比较停药组和继续服药组的结果。这称为随机对照试验（RCT）。在stop -ACEi试验中，我们将随机分配合适的参与者（随机）继续或停止他们的ACEi/ARB治疗，然后对这些参与者进行3年的随访。在将该治疗策略应用于常规临床实践之前，需要进行这项研究。此外，我们还将研究停止这些药物的其他影响，比如对心脏病发作、中风和参与者生活质量的影响。

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.