A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
NCT06578078 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 94
Last updated 2026-03-04
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.
Conditions
- Heart Failure
- Chronic Kidney Diseases
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
Sponsors & Collaborators
-
Fundación para la Investigación del Hospital Clínico de Valencia
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-03
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
Countries
- Spain
Study Locations
More Related Trials
-
OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure
NCT04789239 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Lokelma for RAAS Maximisation in CKD & Heart Failure.
NCT05004363 ·Status: COMPLETED ·Phase: PHASE3
-
A Safety and Pharmacodynamic Study of Healthy Chinese Subjects Administered Sodium Zirconium Cyclosilicate (ZS)
NCT03283267 ·Status: COMPLETED ·Phase: PHASE1
-
Sodium Zirconium Cyclosilicate to Allow Liberal Fruit and Vegetable Intake for Patients With CKD Stage 3b and 4
NCT06365684 ·Status: RECRUITING ·Phase: PHASE4
-
Study of SZC and Enhanced Nutrition Advice Compared to SoC in Dialysis Patients With Hyperkalaemia
NCT04997161 ·Status: TERMINATED ·Phase: PHASE4
-
The Cardioprotective Effects of Improving Potassium Variability in Maintenance Hemodialysis Patients
NCT06736184 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease
NCT04727528 ·Status: TERMINATED ·Phase: PHASE3
-
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
NCT03303521 ·Status: COMPLETED ·Phase: PHASE3
-
Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia
NCT03172702 ·Status: COMPLETED ·Phase: PHASE3
-
Hyperkalaemia and Its Impact on Therapy with RAASi
NCT04249648 ·Status: COMPLETED
-
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia.
NCT03528681 ·Status: COMPLETED ·Phase: PHASE3
-
SZC Versus SPS for Treatment of Hyperkalemia in Hemodialysis Patients
NCT06029179 ·Status: COMPLETED ·Phase: NA
-
An Open-label Study to Assess Safety and Efficacy of SZC in Paediatric Patients With Hyperkalaemia
NCT03813407 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease
NCT01130597 ·Status: COMPLETED ·Phase: PHASE2
-
IMpact of hyPeRkalaemia on thErapy With Renin angiotenSin aldoSterone System Inhibitors
NCT04510792 ·Status: WITHDRAWN
-
Examination of Potassium Levels in Saliva in ESRD Patients
NCT02596386 ·Status: UNKNOWN
-
A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia
NCT02875834 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Early, seQUential Oral dIuretic Nephron blockAde In Acute Heart Failure
NCT04062760 ·Status: UNKNOWN ·Phase: PHASE4
-
Effect of Sodium Intake on Brain Natriuretic Peptide Levels in Patients With Heart Failure
NCT03351283 ·Status: COMPLETED ·Phase: NA
-
Natriuresis-Guided Diuretic Therapy in Patients With Acute Heart Failure With Reduced Ejection Fraction and Chronic Kidney Disease
NCT06203236 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Sequential Nephron Blockade in Acute Heart Failure
NCT04163588 ·Status: UNKNOWN ·Phase: PHASE3
-
Sodium Management in Acute and Chronic Heart Failure
NCT01156337 ·Status: COMPLETED
-
An Observational Prospective Cohort Study for Long-term Management of Hyperkalemia in Patients With Chronic Kidney Disease or Heart Failure
NCT05297409 ·Status: COMPLETED
-
PREVENTION OF WORSENING RENAL FUNCTION OF INTRAVENUS ALBUMIN IN HEART FAILURE PATIENTS
NCT06630923 ·Status: RECRUITING ·Phase: PHASE3
-
Aliskiren and Renin Inhibition in Diastolic Heart Failure
NCT00773084 ·Status: WITHDRAWN ·Phase: NA