Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06578078
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENEKA
Brief 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
Detailed Description:
This is a randomized clinical trial multicentre parallel group open label to evaluate the use of sodium zirconium cyclosilicate SZC to optimize RAASi therapy in patients with heart failure and chronic kidney disease through up-titration of ACEi ARB ARNI or MRA therapy according to clinical guidelines 1 without inducing clinically significant hyperkalemia Eligible subjects will have been admitted to hospital because of an HF NYHA I- III decompensation will have required intravenous diuretics and will have had mild hyperkalaemic values that needed stabilization or be at risk of developing hyperkalaemia Subjects will be randomised in a 11 ratio to receive SZC or none standard of care treatment without potassium binders for 3 months while optimizing RAASi therapies according to the European Society of Cardiology ESC guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None