Abstract
BackgroundBlood 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.MethodsThe 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.ResultsThe 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.
Highlights
Chronic kidney disease (CKD), Stages 3–5, affects 1 in 10 adults in the UK and reflects progressive scarring of the kidneys regardless of the original disease and is associated with a high prevalence of cardiovascular disease [1]
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)
The rationale and trial design are presented here. The results of this trial will show whether discontinuation of angiotensin-converting enzyme inhibitor (ACEi)/ angiotensin receptor blocker (ARB) can improve or stabilize renal function in patients with advanced progressive CKD
Summary
Chronic kidney disease (CKD), Stages 3–5, affects 1 in 10 adults in the UK and reflects progressive scarring of the kidneys regardless of the original disease and is associated with a high prevalence of cardiovascular disease [1]. Studies by Lewis et al [9, 10] and Brenner et al [11] have shown that angiotensin-converting enzyme inhibitor (ACEi) and angiotensin receptor blockers (ARBs) reduce the progression of renal disease [12,13,14,15,16]. 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. 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
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