Multi-centre Randomised Controlled Trial of Angiotensin Converting Enzyme inhibitor (ACEi) / Angiotensin Receptor Blocker (ARB) withdrawal in advanced renal disease; The STOP-ACEi Trial
Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust
Chronic kidney disease (CKD) affects 1 in 10 adults in the UK and describes progressive loss of kidney function 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 replacement of kidney function by dialysis or transplantation is required. Kidney disease is expensive with a high proportion of the health-care budget spent on CKD; the cost of dialysis 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 CKD progression . Some people with CKD gain additional protection from Angiotensin Converting Enzyme inhibitors (ACEi) or Angiotensin Receptor Blockers (ARBs). These drugs treat high BP but also slow CKD progression by other means.
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. This indicates that in some patients the very tablets used to protect the kidneys may be contributing to a harmful decline in their function by some currently unknown mechanism.
To date, research on this is observational and a study to confirm the association between stopping these drugs and stabilisation of kidney function is required. In the STOP-ACEi trial we will randomly allocate suitable participants to either continue or stop their ACEi/ARB treatment and follow-up 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 cardiovascular effects and participant quality of life.
Yorkshire & The Humber - Leeds East Research Ethics Committee
Date of REC Opinion
29 Jan 2014
Further Information Favourable Opinion