A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients

Exclusion Criteria

• •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
• •Patients undergoing treatment with potassium binders.
• •Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment.
• •Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
• •QTc(f) \> 550 msec.
• •History of QT prolongation associated with other medications that required discontinuation of that medication.
• •Congenital long QT syndrome.
• •Prior history of hypersensitivity to a RAAS blocker drug, including but not limited to development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopenia requiring treatment modification. Addison's disease or other causes of hypoaldosteronism.
• •Patients with a known hypersensitivity to SZC or any of the excipients of the product.
• •Individuals treated with potassium binding resins such as sodium polystyrene sulfonate (SPS, e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®) within 7 days prior to the first dose of study drug.
• •Treated with potassium supplements within 7 days prior to randomization. 15. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
• •Known to have tested positive for human immunodeficiency virus.
• •Known history of drug or alcohol abuse within 3 year of screening.
• •Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
• •Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
• •Previous enrolment in the present study.
• •Participation in another clinical study with an investigational product during the last 3 months.