At a glance
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Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients With Symptomatic Heart Failure With Reduced Ejection Fraction and Receiving Spironolactone
In Brief
A Phase 4 clinical trial evaluating Sodium zirconium cyclosilicate, Placebo, and 1 other intervention for Hyperkalaemia and Heart Failure With Reduced Ejection Fraction. Completed, enrolled 366 participants across 89 sites in 8 countries.
Detailed Summary
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).
Study Details
Timeline
Interventions
Investigational medicinal product
Placebo comparator
Background intervention. During the run-in phase, spironolactone will be initiated/uptitrated up to a maximum of 50 mg per day. During the randomized withdrawal phase the spironolactone dose at the end of the run-in phase will be maintained.