Potassium Reduction Initiative to Optimize RAAS Inhibition Therapy With Sodium Zirconium Cyclosilicate in Heart Failure

Summary

This is an international, multicentre, parallel-group, randomised, double-blind, placebo controlled, phase II study to evaluate the benefits and risks of using sodium zirconium cyclosilicate (ZS) to initiate and intensify renin angiotensin aldosterone system inhibitor (RAASi) therapy in heart failure patients.

Timeline

Start

2018-06-26

Primary completion

2020-05-22

Completion

2020-05-22

Outcome

Missed primary endpoint

Stopped: “Study stopped early due to the COVID-19 pandemic”

registry analysis (superiority test); Sodium Zirconium Cyclosilicate vs Placebo; p = 0.426; F-test NCT03532009 ↗

paper There was no statistically significant difference in the distribution of patients by RAAS inhibitor treatment categories at 3 months (P = 0.43). PMID 36564955 ↗

Publications

• Tardif JC, Rouleau J, Chertow GM, Al-Shurbaji A, Lisovskaja V, Gustavson S, Zhao Y, Bouabdallaoui N, Desai AS, Chernyavskiy A, Evsina M, Merkely B, McMurray JJV, Pfeffer MA. Potassium reduction with sodium zirconium cyclosilicate in patients with heart failure. ESC Heart Fail. 2023 Apr;10(2):1066-1076. doi: 10.1002/ehf2.14268. Epub 2022 Dec 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sodium Zirconium Cyclosilicate	Other / unclassified	5 g	Oral

Indications