MO214EVALUATION OF THE EFFECT OF A POTASSIUM BINDER ON ARRHYTHMIA-RELATED CARDIOVASCULAR OUTCOMES IN PATIENTS ON CHRONIC HAEMODIALYSIS WITH RECURRENT HYPERKALAEMIA: DESIGN AND RATIONALE FOR THE SODIUM ZIRCONIUM CYCLOSILICATE DIALIZE-OUTCOMES STUDY

Abstract Background and Aims Patients with end-stage renal disease (ESRD) on chronic haemodialysis are at an elevated risk of arrhythmias that can increase the sudden cardiac death (SCD) stroke, along need for hospitalisation interventions. These may be exacerbated by pre-dialysis hyperkalaemia rapid serum potassium (sK+) shifts occur during after sessions. The DIALIZE study (NCT03303521) demonstrated sodium zirconium cyclosilicate (SZC) was effective well-tolerated treatment hyperkalaemia, when administered once-daily non-dialysis days 8 weeks in patients ESRD undergoing haemodialysis. DIALIZE-Outcomes (EudraCT 2020-005561-14) will evaluate effect SZC arrhythmia-related cardiovascular (CV) outcomes recurrent hyperkalaemia. Method is international, multicentre, randomised, double-blind, parallel-group, placebo-controlled study, to conducted ∼300 sites across ∼20 countries. Adults (≥18 years age) three times weekly sK+ ≥5.5 mmol/L long interdialytic interval (LIDI) eligible enrolment. Approximately 2300 randomised 1:1 or placebo (Figure), starting 5 g orally once daily (4 days/week) uptitrated increments (maximum 15 g) achieve 4.0–5.0 LIDI. Dose adjustments uptitration phase guided monitoring, as per clinical practice. primary objective efficacy versus reducing incidence composite endpoint time first occurrence SCD, stroke hospitalisation/intervention/emergency department visit due (atrial fibrillation, bradycardia, asystole, ventricular tachyarrhythmia). Secondary endpoints include maintaining normokalaemia (sK+ 4.0–5.5 LIDI) preventing severe ≥6.5 1 year (assessed through measurement 12-month visit), CV outcomes. Safety tolerability also evaluated. event-driven, remaining until a pre-specified number events (770) has occurred. anticipated average period ∼25 months. Conclusion evaluation K+ binder improving findings provide valuable information help further our understanding relationship between morbidity mortality haemodialysis, optimise regimens this high SCD population.