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.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Provision of informed consent form prior to any study specific procedures, sampling and analysis.
Individuals must be ≥ 70 years of age at the time of signing the informed consent form.
Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
Limited life expectancy (less than 1 year) according to clinician's criteria, such as but not limited to malignancy, with life expectancy of less than 2 years based on investigator's clinical judgement.
sK >6 mEq/litre or <4.5mEq/litre or history of hypokalemic episodes (S-K<3.5 mEq/L) during the last year.
Patients on haemodialysis or haemofiltration
NYHA functional class IV
Parallel
Sodium Zirconium Cyclosilicate
DrugUse 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)
DrugStandard of care treatment (RAASi therapy) without use of sodium zirconium cyclosilicate
Number 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.
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.
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.
Number of patients achieving at least 50% of the target doses of MRA since the screening visit (V0) to 3 months after study inclusion (V9)
To assess the number of patients that achieve at least 50% of the target dose recommended in guidelines of Mineralocorticoid receptor antagonist (MRA).
Number of patients increasing 50% of MRA doses since the screening visit (V0) to 3 months after study inclusion (V9)
To assess the number of patients that achieve at least 50% of the target dose recommended in guidelines of Mineralocorticoid receptor antagonist (MRA)
Number of patients achieving at least 50% of the target doses of MRA and RAASi since the screening visit (V0) to 3 months after study inclusion (V9)
To analyse the number of patients achieving at least 50% of the recommended target dose of MRA and achieving at least 50% of the guidelines recommended target dose of RAASi
Number of patients increasing 50% of MRA and RAASi doses since the screening visit (V0) to 3 months after study inclusion (V9)
To analyse the number of patients achieving at least 50% of the recommended target dose of MRA and achieving at least 50% of the guidelines recommended target dose of RAASi
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