Efficacy and Safety of Sodium Zirconium Cyclosilicate in the Management of Hyperkalemia in Patients with Heart Failure with Reduced and Mildly Reduced Ejection Fraction and Chronic Kidney Disease Treated with Spironolactone: rational for and design of the REGISTA-K trial.

IF 6.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Journal of Cardiac Failure Pub Date : 2024-12-19 DOI:10.1016/j.cardfail.2024.11.017
Keisuke Kida, Yu Horiuchi, Shuntaro Sato, Takeshi Kitai, Takahiro Okumura, Teruhiko Imamura, Takafumi Sakamoto, Yuya Matsue
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引用次数: 0

Abstract

Background: To evaluate whether sodium zirconium cyclosilicate (SZC) enables the uptitration of spironolactone without increasing the risk of hyper- and hypokalemia in patients with heart failure with reduced and mildly reduced ejection fraction (HFrEF and HFmrEF) and moderate/severe chronic kidney disease (CKD) who developed hyperkalemia during treatment with suboptimal spironolactone dose.

Methods: The REGISTA-K is a randomized, double-blind, placebo-controlled, multicenter trial that examined the efficacy and safety of SZC in uptitrating spironolactone without the occurrence of hyperkalemia or hypokalemia. A total of 266 patients with HFrEF and HFmrEF and hyperkalemia will be randomized in a 1:1 ratio to receive either SZC or placebo after treating hyperkalemia with SZC at 25 sites in Japan. The study enrolls patients with left ventricular EF <50%, moderate/severe CKD (estimated glomerular filtration rate 15-45 mL/min/1.73 m2), serum potassium level >5.0 mEq/L, and undergoing 12.5-37.5 mg spironolactone treatment. The primary endpoint is successful administration of 50 mg/day spironolactone at 16 weeks follow-up without the need for rescue therapy for either hypokalemia or hyperkalemia.

Conclusions: REGISTA-K will evaluate the efficacy and safety of SZC as adjunctive therapy in uptitrating spironolactone in patients with HFrEF and HFmrEF with moderate to severe renal dysfunction and hyperkalemia.

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来源期刊
Journal of Cardiac Failure
Journal of Cardiac Failure 医学-心血管系统
CiteScore
7.80
自引率
8.30%
发文量
653
审稿时长
21 days
期刊介绍: Journal of Cardiac Failure publishes original, peer-reviewed communications of scientific excellence and review articles on clinical research, basic human studies, animal studies, and bench research with potential clinical applications to heart failure - pathogenesis, etiology, epidemiology, pathophysiological mechanisms, assessment, prevention, and treatment.
期刊最新文献
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