Overview

Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone

Status:
Recruiting
Trial end date:
2023-04-05
Target enrollment:
0
Participant gender:
All
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 without assistance of rescue therapy for hyperkalaemia (HK).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Spironolactone
Criteria
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 either:

- Have a history of HK (sK+ >5.0 mEq/L) within the prior 24 months and eGFR ≥30
mL/min/1.73 m2, or

- sK+ ≥4.5 mEq/L and eGFR 30 to 60 mL/min/1.73 m2 and/or 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) (stable dose for ≥4
weeks)

- Not on spironolactone or eplerenone, or on low-dose spironolactone (<25 mg daily).

- Receiving beta-blocker (stable dose for ≥4 weeks) 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 due to HF

- Previous cardiac transplantation or implantation of a ventricular assistance device
(VAD) or similar device, or transplantation or implantation expected after
randomisation