Potassium reduction with sodium zirconium cyclosilicate in patients with heart failure.

Montreal Heart Institute, Université de Montréal, 5000 Belanger Street East, Montreal, H1T1C8, Quebec, Canada. Stanford University School of Medicine, Palo Alto, CA, USA. AstraZeneca, Stockholm, Sweden. Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. E. Meshalkin National Medical Research Center, Ministry of Health of the Russia Federation, Moscow, Russia. Aramil City Hospital, Aramil, Russia. Semmelweis Universtiy Heart and Vascular Center, Budapest, Hungary. Institute of Cardiovascular and Medical Sciences, British Heart Foundation Centre of Research, University of Glasgow, Glasgow, UK.

ESC heart failure. 2023;(2):1066-1076
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Abstract

AIMS: Several patients with heart failure and reduced ejection fraction (HFrEF) do not receive renin-angiotensin-aldosterone system (RAAS) inhibitors at the recommended dose or at all, frequently due to actual or feared hyperkalaemia. Sodium zirconium cyclosilicate (SZC) is an orally administered non-absorbed intestinal potassium binder proven to lower serum potassium concentrations. METHODS AND RESULTS PRIORITIZE-HF was an international, multicentre, parallel-group, randomized, double-blind, placebo-controlled study to evaluate the benefits and risks of using SZC to intensify RAAS inhibitor therapy. Patients with symptomatic HFrEF were eligible and randomly assigned to receive SZC 5 g or placebo once daily for 12 weeks. Doses of study medication and RAAS inhibitors were titrated during the treatment period. The primary endpoint was the proportion of patients at 12 weeks in the following categories: (i) any RAAS inhibitor at less than target dose, and no MRA; (ii) any RAAS inhibitor at target dose and no MRA; (ii) MRA at less than target dose; and (iv) MRA at target dose. Due to challenges in participant management related to the COVID-19 pandemic, the study was prematurely terminated with 182 randomized patients. There was no statistically significant difference in the distribution of patients by RAAS inhibitor treatment categories at 3 months (P = 0.43). The proportion of patients at target MRA dose was numerically higher in the SZC group (56.4%) compared with the placebo group (47.0%). Overall, SZC was well tolerated. CONCLUSIONS PRIORITIZE-HF was terminated prematurely due to COVID-19 and did not demonstrate a statistically significant increase in the intensity of RAAS inhibitor therapies with the potassium-reducing agent SZC compared with placebo.

Methodological quality

Publication Type : Randomized Controlled Trial

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