Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone

INCLUSION CRITERIA

• Adults aged ≥18 years

• Potassium and estimated glomerular filtration rate (eGFR):

• Cohort 1: sK+ 5.1-5.9 mEq/L at screening/study enrolment and eGFR ≥30 mL/min/1.73 m2; OR

• Cohort 2: Normokalaemic (sK+ 3.5-5.0 mEq/L) at screening and 'at risk' of developing HK defined as any of the following:

• Have a history of HK (sK+ >5.0 mEq/L) within the prior 36 months and eGFR ≥30 mL/min/1.73 m2; or

• sK+ 4.5-5.0 mEq/L and eGFR 30 to 60 mL/min/1.73 m2; or

• sK+ 4.5-5.0 mEq/L, and age >75 years

• Symptomatic HFrEF (New York Heart Association [NYHA] class II-IV), which has been present for at least 3 months

• Left ventricular ejection fraction (LVEF) ≤40%

• Receiving angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi)

• Not on or on low-dose spironolactone or eplerenone (<25 mg daily)

• Receiving beta-blocker unless contraindicated

EXCLUSION CRITERIA

• Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or severe stenotic valve disease as a primary cause of HF

• Current inpatient hospitalisation with unstable HF, defined as any of the following:

• Systolic blood pressure <95 mmHg during the 6 hours prior to screening.

• Intravenous diuretic therapy during the 12 hours prior to screening.

• Use of intravenous inotropic drugs during the 24 hours prior to screening.

• Received mechanical circulatory support during the 48 hours prior to screening

• Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomisation