Actively Recruiting
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2026-03-04
94
Participants Needed
6
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving signed informed consent including compliance with protocol requirements
- Signed informed consent form before any study procedures
- Age 70 years or older at consent
- Confirmed diagnosis of heart failure (NYHA class I-III) with either reduced or preserved ejection fraction
- Previous hospital admission for heart failure decompensation requiring intravenous diuretics
- Stabilized for at least 24-48 hours after heart failure decompensation before randomization
- Confirmed chronic kidney disease with eGFR less than 60 ml/min/1.73 m2
- Receiving standard heart failure care including RAASi and/or mineralocorticoid receptor antagonist treatment stable for at least 4 weeks at maximum tolerated doses
- Currently on RAASi treatment at 75% or less of the maximum recommended dose
- Hyperkalemic patients with serum potassium 5.1-5.9 mmol/L at screening or normokalemic patients at risk of hyperkalemia (history of hyperkalemia in past 24 months and serum potassium between 4.5 and 5.1 mmol/L at inclusion)
You will not qualify if you...
- Life expectancy less than 1 year based on clinical judgment
- Serum potassium greater than 6.0 mmol/L or less than 4.5 mmol/L, or history of hypokalemia (less than 3.5 mmol/L) in the past year
- Currently on hemodialysis or hemofiltration
- NYHA functional class IV heart failure
- Use of potassium binders
- Active cancer undergoing chemotherapy, metastasis, or malignancy requiring treatment
- Symptomatic or uncontrolled atrial fibrillation or sustained ventricular tachycardia (controlled atrial fibrillation allowed)
- QTc interval greater than 550 msec or history of drug-induced QT prolongation
- Congenital long QT syndrome
- History of hypersensitivity to RAAS blockers including angioedema or blood disorders requiring treatment changes
- Addison's disease or other hypoaldosteronism causes
- Known hypersensitivity to sodium zirconium cyclosilicate or its ingredients
- Use of potassium binding resins or potassium supplements within 7 days before study drug
- Positive hepatitis B or C serology at screening
- Known HIV infection
- History of drug or alcohol abuse within 3 years
- Involvement in the study planning or conduct
- Investigator judgment that participant is unlikely to comply with study procedures
- Previous enrollment in this study
- Participation in another investigational drug study within the past 3 months
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Not Yet Recruiting
2
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain, 28914
Not Yet Recruiting
3
Hospital Universitario Nuestra Señora del Perpétuo Socorro
Albacete, Spain, 02006
Actively Recruiting
4
Hospital Universitario de Burgos
Burgos, Spain, 09006
Actively Recruiting
5
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Not Yet Recruiting
6
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
C
Clara Bonanad Lozano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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