Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F24%3AA2503AIG" target="_blank" >RIV/61988987:17110/24:A2503AIG - isvavai.cz</a>
Result on the web
<a href="https://linkinghub.elsevier.com/retrieve/pii/S2213177924004001" target="_blank" >https://linkinghub.elsevier.com/retrieve/pii/S2213177924004001</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.jchf.2024.05.003" target="_blank" >10.1016/j.jchf.2024.05.003</a>
Alternative languages
Result language
angličtina
Original language name
Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia
Original language description
Background: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced ejection fraction (HFrEF). However, MRAs are often underused because of hyperkalemia concerns. Objectives: The purpose of this study was to assess whether sodium zirconium cyclosilicate (SZC), a nonabsorbed crystal that traps and rapidly lowers potassium, enables MRA use in patients with HFrEF and prevalent hyperkalemia (or at high risk). Methods: REALIZE-K is a prospective, double-blind, placebo-controlled trial in patients with HFrEF (NYHA functional class II-IV; left ventricular ejection fraction <= 40%), optimal therapy (except MRA), and prevalent hyperkalemia (or at high risk). During the open-label run-in, all participants underwent protocol-mandated spironolactone titration (target: 50 mg daily); those with prevalent (cohort 1) or incident (cohort 2) hyperkalemia during titration started SZC. Participants achieving normokalemia while on spironolactone >= 25 mg daily were randomized to continuing SZC or matching placebo for 6 months. The primary composite endpoint was proportion of participants with optimal response (normokalemia, on spironolactone >= 25 mg daily, no rescue for hyperkalemia [months 1-6]). Results: Of 365 patients (run-in), 202 were randomized. Baseline characteristics included mean age 70 years, prevalent comorbidities (78% estimated glomerular filtration rate <60 mL/min/1.73 m(2), 38% atrial fibrillation/flutter), high N-terminal pro B-type natriuretic peptide (median 1,136 pg/mL), and high HFrEF therapy use (64% sacubitril/valsartan, 96% beta-blocker, 42% sodium glucose co-transporter 2 inhibitor). At randomization, 78% were receiving spironolactone 50 mg daily. Conclusions: REALIZE-K is the first trial to evaluate whether SZC can enable rapid and safe MRA optimization and long-term continuation in patients with HFrEF and prevalent/high risk of hyperkalemia.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2024
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
JACC-HEART FAILURE
ISSN
2213-1779
e-ISSN
2213-1787
Volume of the periodical
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Issue of the periodical within the volume
10
Country of publishing house
GB - UNITED KINGDOM
Number of pages
10
Pages from-to
1707-1716
UT code for WoS article
001338479500001
EID of the result in the Scopus database
2-s2.0-85195696892