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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age70+
SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sodium Zirconium Cyclosilicate
  • Standard of care treatment (RAASi therapy)

Treatment groups

94 Participants
are divided into 2 treatment groups