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