Heart failure (HF) and Chronic Kidney Disease (CKD) patients are frequently not administered renin-angiotensin aldosterone system inhibitor (RAASi) therapies at recommended doses due to hyperkalaemia, despite proven mortality and morbidity benefits. Sodium zirconium cyclosilicate (SZC) is a nonabsorbed potassium binder proven to lower serum potassium (S-K) and maintain normokalaemia. The purpose is to assess if a treatment regimen containing SZC will allow RAASi therapies to be optimized to target doses in patients with heart failure, chronic kidney disease and elevated serum potassium or at risk of developing elevated serum potassium.
This is a randomized clinical trial, multicentre, parallel group, open label, to evaluate the use of sodium zirconium cyclosilicate (SZC) to optimize RAASi therapy in patients with heart failure and chronic kidney disease, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines (1), without inducing clinically significant hyperkalemia. Eligible subjects will have been admitted to hospital because of an HF (NYHA I- III) decompensation, will have required intravenous diuretics and will have had mild hyperkalaemic values that needed stabilization or be at risk of developing hyperkalaemia. Subjects will be randomised in a 1:1 ratio to receive SZC or none (standard of care treatment without potassium binders) for 3 months while optimizing RAASi therapies according to the European Society of Cardiology (ESC) guidelines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
Use of sodium zirconium cyclosilicate to optimize RAASi therapy, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines
Standard of care treatment (RAASi therapy) without use of sodium zirconium cyclosilicate
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Severo Ochoa
Leganés, Madrid, Spain
NOT_YET_RECRUITINGHospital Universitario Nuestra Señora del Perpétuo Socorro
Albacete, Spain
RECRUITINGHospital Universitario de Burgos
Burgos, Spain
RECRUITINGHospital Universitario Reina Sofía
Córdoba, Spain
NOT_YET_RECRUITINGHospital Clínico Universitario de Valencia
Valencia, Spain
RECRUITINGNumber of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
To compare the number of patients achieving an increase of at least 25% of RAASi according to guideline-recommended target doses, in the arm treated with Lokelma plus RAASi versus the arm treated with RAASi without K+ binder, at 3 months after study inclusion.
Time frame: Through study completion, an average of 3 months
Number of patients achieving at least 50% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
To assess the number of patients achieving at least 50% of the target dose of RAASi recommended in the guidelines.
Time frame: Through study completion, an average of 3 months
Number of patients increasing 50% of RAASi doses since the screening visit (V0) to 3 months after study inclusion (V9)
To assess the number of patients achieving at least 50% of the target dose of RAASi recommended in the guidelines.
Time frame: Through study completion, an average of 3 months
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