Actively Recruiting
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 by Optimizing RAASi Use With Sodium Zirconium Cyclosilicate
Led by Fundación para la Investigación del Hospital Clínico de Valencia · Updated on 2026-03-04
94
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of sodium zirconium cyclosilicate (SZC) to help optimize renin-angiotensin aldosterone system inhibitor (RAASi) therapies in elderly patients aged 70 and older who have heart failure and chronic kidney disease. Many patients with these conditions do not receive recommended RAASi doses because of elevated potassium levels, which can be dangerous. This study aims to see if adding SZC allows safer and more effective use of RAASi medications by managing potassium levels. This is a randomized, open-label clinical trial where eligible participants who have been hospitalized for heart failure worsening and have mild or at-risk hyperkalemia will be assigned to one of two groups. One group receives SZC along with standard RAASi treatment, while the other receives RAASi treatment alone without potassium binders. The treatment period lasts three months, during which RAASi doses are adjusted following European Society of Cardiology guidelines. Participants will be monitored from screening through three months of treatment to measure how many can increase their RAASi doses by at least 25%. Evaluations include clinical assessments, potassium level monitoring, and adherence to therapy. The study will also track secondary outcomes related to higher dose increases. Safety and treatment effects will be observed throughout the trial, which is expected to provide important insights for managing these conditions in elderly patients.
CONDITIONS
Brief 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...
- Able to provide signed informed consent and comply with study requirements
- Aged 70 years or older at consent
- Confirmed diagnosis of heart failure (NYHA class I-III) with reduced or preserved ejection fraction
- Previously hospitalized for heart failure worsening requiring intravenous diuretics
- Stabilized for at least 24-48 hours after heart failure decompensation before randomization
- Confirmed chronic kidney disease with eGFR below 60 ml/min/1.73 m²
- Receiving stable background heart failure treatment including RAASi or MRA for at least 4 weeks
- Using RAASi treatment at 75% or less of the maximum recommended dose
- Hyperkalemic at screening (serum potassium 5.1-5.9 mmol/L) or normokalemic but at risk of hyperkalemia with prior history and current potassium levels between 4.5 and 5.1 mmol/L
You will not qualify if you...
- Life expectancy less than 1 year based on clinical judgement
- Serum potassium above 6 mEq/L or below 4.5 mEq/L, or history of low potassium episodes in past year
- Currently on hemodialysis or hemofiltration
- NYHA functional class IV heart failure
- Currently treated with potassium binders
- Active cancer requiring chemotherapy, metastasis, or malignancy needing treatment
- Symptomatic or uncontrolled atrial fibrillation or sustained ventricular tachycardia
- QTc interval above 550 msec or congenital long QT syndrome
- History of hypersensitivity to RAAS blockers or related side effects
- Known hypersensitivity to sodium zirconium cyclosilicate or its ingredients
- Recent use (within 7 days) of other potassium binding resins or potassium supplements
- Positive hepatitis B or C screening or HIV infection
- History of drug or alcohol abuse within 3 years
- Involvement in study planning or conduct
- Unlikely to comply with study procedures
- Previous enrollment in this study
- Participation in another investigational study within last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive treatment with either sodium zirconium cyclosilicate alongside standard RAASi therapy or standard RAASi therapy alone to optimize heart failure management according to clinical guidelines.
Multiple visits during treatment period for therapy optimization
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here