Status:
COMPLETED
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
Lead Sponsor:
AstraZeneca
Conditions:
Hyperkalaemia
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18-130 years
Phase:
PHASE4
Brief Summary
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily wi...
Detailed Description
REALIZE-K is a Phase 4, multinational, multicenter, double-blind, placebo-controlled, randomized-withdrawal, parallel-group study that includes the following 3 phases: screening, 4-6 week open-label r...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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)
- Not on or on low-dose spironolactone or eplerenone (\<25 mg daily)
- Receiving beta-blocker unless contraindicated
- EXCLUSION CRITERIA
- 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 hospitalisation with unstable HF, defined as any of the following:
- Systolic blood pressure \<95 mmHg during the 6 hours prior to screening.
- Intravenous diuretic therapy during the 12 hours prior to screening.
- Use of intravenous inotropic drugs during the 24 hours prior to screening.
- Received mechanical circulatory support during the 48 hours prior to screening
- Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomisation
Exclusion
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT04676646
Start Date
March 8 2021
End Date
July 15 2024
Last Update
July 9 2025
Active Locations (89)
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1
Research Site
Fairhope, Alabama, United States, 36532
2
Research Site
Los Angeles, California, United States, 90033
3
Research Site
Torrance, California, United States, 90502
4
Research Site
Evanston, Illinois, United States, 60202