RecruitingPhase 3NCT06578078

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

A Randomized Clinical Trial to Define the Best Strategy for the Management of Heart Failure and Chronic Kidney Disease Among Elderly Patients With or at High Risk of hyperKalemia in Span by Optimizing the Use of RAASi With SZC

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

94 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Chronic Kidney Diseases

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

Min Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the best strategy for managing heart failure in elderly patients (70 and older), including optimizing medications, monitoring, and follow-up care to reduce hospitalizations and improve quality of life. **You may be eligible if...** - You are 70 years of age or older - You have a confirmed diagnosis of heart failure (based on standard clinical guidelines) - You are able to provide informed consent **You may NOT be eligible if...** - You have very recent severe heart events (such as a heart attack within the last 3 months) - You have end-stage kidney disease requiring dialysis - You are unable to comply with study follow-up requirements - You are enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSodium Zirconium Cyclosilicate

Use of sodium zirconium cyclosilicate to optimize RAASi therapy, through up-titration of ACEi, ARB, ARNI or MRA therapy according to clinical guidelines

DRUGStandard of care treatment (RAASi therapy)

Standard of care treatment (RAASi therapy) without use of sodium zirconium cyclosilicate

Locations(6)

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Hospital Universitario Nuestra Señora del Perpétuo Socorro

Albacete, Spain

Hospital Universitario de Burgos

Burgos, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT06578078

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