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

Last updated: October 18, 2024
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Overall Status: Active - Recruiting

Phase

3

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

Standard of care treatment (RAASi therapy)

Sodium Zirconium Cyclosilicate

Clinical Study ID

NCT06578078
SENEKA
2024-513971-42-00
  • Ages > 70
  • All Genders

Study Summary

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

Inclusion

Inclusion Criteria:

  • Capable of giving signed informed consent which includes compliance with therequirements and restrictions listed in the informed consent form (ICF) and in thisprotocol.

  • Provision of informed consent form prior to any study specific procedures, samplingand analysis.

  • Individuals must be ≥ 70 years of age at the time of signing the informed consentform.

  • Individuals must have a confirmed diagnosis of Heart Failure (HF) according toclinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).

  • Individuals must have previously been admitted to hospital due to HF decompensationrequiring intravenous diuretics.

  • Individuals must have been stabilised for at least 24-48h of their HF decompensationbefore randomisation.

  • Individuals must have a confirmed diagnosis of Chronic Kidney Disease defined as arenal impairment of eGFR less than 60ml/min/1.73 m2.

  • Individuals receiving background standard of care for HF and treated according tointernational guidelines. Specific treatment should include RAASi and/or MRAtreatment and at least should have been stable for ≥ 4 weeks at maximum tolerateddoses.

  • Patients on RAASi blocker treatment with less than or equal to 75% of the maximumrecommended dose.

  • Hyperkalemic patients (sK+ 5.1-5.9 mmol/L at screening / study enrolment) orNormokalemic patients at risk of developing HK defining as having a history ofhyperkalaemia (sK+ >5.0 mEq/L) within the prior 24 months and sK+ ≥4.5 mEq/L ≤ 5.1mEq/L at inclusion

Exclusion

Exclusion Criteria:

  • Limited life expectancy (less than 1 year) according to clinician's criteria, suchas but not limited to malignancy, with life expectancy of less than 2 years based oninvestigator'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 requiringtreatment.

  • Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomaticsustained ventricular tachycardia. Subjects with atrial fibrillation controlled bymedication are permitted.

  • QTc(f) > 550 msec.

  • History of QT prolongation associated with other medications that requireddiscontinuation of that medication.

  • Congenital long QT syndrome.

  • Prior history of hypersensitivity to a RAAS blocker drug, including but not limitedto development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopeniarequiring treatment modification. Addison's disease or other causes ofhypoaldosteronism.

  • Patients with a known hypersensitivity to SZC or any of the excipients of theproduct.

  • Individuals treated with potassium binding resins such as sodium polystyrenesulfonate (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 viruscore 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 bothInvestigator staff and/or staff at the study site).

  • Judgment by the investigator that the subject should not participate in the study ifthe subject is unlikely to comply with study procedures, restrictions andrequirements.

  • Previous enrolment in the present study.

  • Participation in another clinical study with an investigational product during thelast 3 months.

Study Design

Total Participants: 94
Treatment Group(s): 2
Primary Treatment: Standard of care treatment (RAASi therapy)
Phase: 3
Study Start date:
October 03, 2024
Estimated Completion Date:
March 30, 2026

Study Description

This is a randomized clinical trial, multicentre, parallel group, open label, to evaluate the use of sodium zirconium cyclosilicate (SZC) to optimize RAASi therapy in patients with heart failure and chronic kidney disease, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines (1), without inducing clinically significant hyperkalemia. Eligible subjects will have been admitted to hospital because of an HF (NYHA I- III) decompensation, will have required intravenous diuretics and will have had mild hyperkalaemic values that needed stabilization or be at risk of developing hyperkalaemia. Subjects will be randomised in a 1:1 ratio to receive SZC or none (standard of care treatment without potassium binders) for 3 months while optimizing RAASi therapies according to the European Society of Cardiology (ESC) guidelines.

Connect with a study center

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid 28922
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa

    Leganés, Madrid 28914
    Spain

    Site Not Available

  • Hospital Universitario Nuestra Señora del Perpétuo Socorro

    Albacete, 02006
    Spain

    Active - Recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006
    Spain

    Active - Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Active - Recruiting

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