Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients with Symptomatic Heart Failure with Reduced Ejection Fraction and Receiving Spironolactone (REALIZE-K) - REALIZE-K

AstraZeneca AB0 sites400 target enrollmentMarch 16, 2023

Overview

No summary available.

Registry

who.int

Start Date

March 16, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Adults aged \=18 years
•\- Potassium and estimated glomerular filtration rate (eGFR):
•\- Cohort 1: sK\+ 5\.1\-5\.9 mEq/L at screening/study enrolment and eGFR \=30 mL/min/1\.73 m2; or
•\- Cohort 2: Normokalaemic (sK\+ 3\.5\-5\.0 mEq/L) at screening and ‘at risk’ of developing HK defined as any of the following:
•\- Have a history of HK (sK\+ \>5\.0 mEq/L) within the prior 36 months and eGFR \=30 mL/min/1\.73 m2, or
•\- sK\+ 4\.5\-5\.0 mEq/L and eGFR 30 to 60 mL/min/1\.73 m2, or
•\- sK\+ 4\.5\-5\.0 mEq/L and age \>75 years
•\- Symptomatic HFrEF (New York Heart Association \[NYHA] class II\-IV), which has been present for at least 3 months
•\- Left ventricular ejection fraction (LVEF) \=40%
•\- Receiving angiotensin\-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor\-Neprilysin inhibitor (ARNi)

•\- Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or severe stenotic valve disease as a primary cause of HF
•\- Current inpatient hospitalization with unstable HF, defined as any of the following:
•a. SBP \<95 mmHg during the 6 hours prior to screening.
•b. Intravenous diuretic therapy during the 12 hours prior to screening.
•c. Use of intravenous inotropic drugs during the 24 hours prior to screening.
•d. Received mechanical circulatory support during the 48 hours prior to screening.
•\- Type 1 myocardial infarction (MI), unstable angina, or stroke within 12 weeks prior to enrolment
•\- Coronary revascularisation (percutaneous coronary intervention \[PCI] or coronary artery bypass grafting \[CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these procedures
•\- Implantation of a Cardiac Resynchronisation Therapy (CRT) device within 12 weeks prior to enrolment or intent to perform atrial fibrillation ablation or to implant a CRT device
•\- Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.