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

Bhandari, S., Ives, N., Brettell, E. A., Valente, M., Cockwell, P., Topham, P. S., Cleland, J. G.F. , Khwaja, A. and El Nahas, M. (2016) Multicentre randomized controlled trial of angiotensin-converting enzyme inhibitor/angiotensin receptor blocker withdrawal in advanced renal disease: the STOP-ACEi trial. Nephrology Dialysis Transplantation, 31(2), pp. 255-261. (doi: 10.1093/ndt/gfv346) (PMID:26429974) (PMCID:PMC4725389)

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Abstract

Background: 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. Methods: 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. Results: 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.

Item Type:Articles
Additional Information:STOP-ACEi is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership (11/30/07).
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Cleland, Professor John
Authors: Bhandari, S., Ives, N., Brettell, E. A., Valente, M., Cockwell, P., Topham, P. S., Cleland, J. G.F., Khwaja, A., and El Nahas, M.
Subjects:R Medicine > R Medicine (General)
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:Nephrology Dialysis Transplantation
Publisher:Oxford University Press
ISSN:0931-0509
ISSN (Online):1460-2385
Published Online:30 September 2015
Copyright Holders:Copyright © 2015 The Authors
First Published:First published in Nephrology Dialysis Transplantation 31(2): 255-261
Publisher Policy:Reproduced under a Creative Commons License

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