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

Korábbi kezelés

• Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
• 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.
• Previous enrolment in the present study.
• Participation in another clinical study with an investigational product during the last 3 months.

Más betegség

• 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.
• Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment.
• Patients with a known hypersensitivity to SZC or any of the excipients of the product.
• Known history of drug or alcohol abuse within 3 year of screening.

Laborértékek

• Patients undergoing treatment with potassium binders.
• QTc(f) > 550 msec.
• History of QT prolongation associated with other medications that required discontinuation of that medication.
• Congenital long QT syndrome.
• 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.

Egyéb

• Patients on haemodialysis or haemofiltration
• NYHA functional class IV
• Known to have tested positive for human immunodeficiency virus.
• 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.

• 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).
• Individuals must have previously been admitted to hospital due to HF decompensation requiring intravenous diuretics.
• Individuals must have been stabilised for at least 24-48h of their HF decompensation before randomisation.
• Individuals must have a confirmed diagnosis of Chronic Kidney Disease defined as a renal impairment of eGFR less than 60ml/min/1.73 m2.
• Individuals receiving background standard of care for HF and treated according to international guidelines. Specific treatment should include RAASi and/or MRA treatment and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.
• Patients on RAASi blocker treatment with less than or equal to 75% of the maximum recommended dose.
• Hyperkalemic patients (sK+ 5.1-5.9 mmol/L at screening / study enrolment) or Normokalemic patients at risk of developing HK defining as having a history of hyperkalaemia (sK+ >5.0 mEq/L) within the prior 24 months and sK+ ≥4.5 mEq/L ≤ 5.1 mEq/L at inclusion