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RECRUITING
NCT06578078
PHASE3

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

Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2024-10-03

Completion Date

2026-12-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

Sodium 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

DRUG

Standard 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