Aldosterone bloCkade for Health Improvement EValuation in End-stage Renal Disease

Summary

Individuals receiving dialysis are at risk of heart failure and heart related death. There is an urgent need for treatments that reduce the risk of these problems in patients that require dialysis. Spironolactone is a pill used to prevent heart failure and related deaths in patients that do not require dialysis. It works by blocking a hormone (aldosterone) in your body that causes high blood pressure and can damage the heart. Although spironolactone is very effective in patients that do not require dialysis, we do not know if spironolactone is effective in dialysis patients. Our research will help determine if spironolactone reduces heart failure and heart related deaths in dialysis patients. The purpose of this study is to determine if spironolactone reduces death or hospitalization for heart failure and is well tolerated in patients that require dialysis.

Timeline

Start

2017-07-07

Primary completion

2025-03-14

Completion

2025-03-14

Publications

• Background Quach K, Lvtvyn L, Baigent C, Bueti J, Garg AX, Hawley C, Haynes R, Manns B, Perkovic V, Rabbat CG, Wald R, Walsh M. The Safety and Efficacy of Mineralocorticoid Receptor Antagonists in Patients Who Require Dialysis: A Systematic Review and Meta-analysis. Am J Kidney Dis. 2016 Oct;68(4):591-598. doi: 10.1053/j.ajkd.2016.04.011. Epub 2016 Jun 3.
• Background Walsh M, Manns B, Garg AX, Bueti J, Rabbat C, Smyth A, Tyrwhitt J, Bosch J, Gao P, Devereaux PJ, Wald R. The Safety of Eplerenone in Hemodialysis Patients: A Noninferiority Randomized Controlled Trial. Clin J Am Soc Nephrol. 2015 Sep 4;10(9):1602-8. doi: 10.2215/CJN.12371214. Epub 2015 Jul 2.
• Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Reis G, Xavier D, Liu WJ, Zuo L, Wang AY, Felix C, Sola L, Arici M, Villanueva R, Jha V, Precoma D, Rabbat CG, Alavudeen SS, Faruqui AR, Lopez-Flecher M, Pyne L, Wald R, Yuan F, Balasubramanian K, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial. Lancet. 2025 Aug 16;406(10504):695-704. doi: 10.1016/S0140-6736(25)01198-5.
• Walsh M, Collister D, Gallagher M, Mark PB, de Zoysa JR, Tyrwhitt J, Tennankore K, Sola L, Reis G, Xavier D, Villanueva R, Liu WJ, Felix C, Zuo L, Arici M, Jha V, Wald R, Wang AY, Faruqui AR, Yuan F, Lee SF, Kuptsova A, Christou C, Devereaux PJ; ACHIEVE Investigators. The Aldosterone Blockade for Health Improvement Evaluation in End-Stage Renal Disease (ACHIEVE) Trial: Rationale and Clinical Research Protocol. Can J Kidney Health Dis. 2025 Jun 3;12:20543581251348187. doi: 10.1177/20543581251348187. eCollection 2025.
• Huang B, McDowell G, Rao A, Lip GYH. Mineralocorticoid receptor antagonist for chronic kidney disease, risk or benefit? J Hypertens. 2024 Mar 1;42(3):396-398. doi: 10.1097/HJH.0000000000003643. Epub 2024 Feb 1. No abstract available.
• Soomro QH, Charytan DM. Mineralocorticoid Receptor Antagonists and Cardiovascular Health with Kidney Failure. Clin J Am Soc Nephrol. 2021 Jun;16(6):843-845. doi: 10.2215/CJN.04460421. No abstract available.
• Collister D, Mbuagbaw L, Guyatt G, Devereaux PJ, Tennankore KK, Reis G, Sola L, Xavier D, Jha V, Gallagher M, Dans AL, Liu W, de Zoysa J, Felix C, Mark PB, Li Z, Tyrwhitt J, Wilkinson J, Sheridan P, Yuan F, Walsh M; ACHIEVE investigators. Three week compared to seven week run-in period length and the assessment of pre-randomization adherence: A study within a trial. Contemp Clin Trials. 2021 Aug;107:106466. doi: 10.1016/j.cct.2021.106466. Epub 2021 Jun 5.
• Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

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