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

Completed · Phase 4 · Has a placebo group

Conditions studied: Hyperkalaemia, Heart Failure With Reduced Ejection Fraction

In brief

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).

Key facts

Study ID

NCT04676646

Run by

AstraZeneca

People needed

366

Starts

2021-03-08

Expected to finish

2024-07-15

Last updated by the study team

2025-07-09

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Torrance, California, United States
• Research Site — Evanston, Illinois, United States
• Research Site — Hazel Crest, Illinois, United States
• Research Site — Oak Lawn, Illinois, United States
• Research Site — Kansas City, Missouri, United States
• Research Site — New York, New York, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Houston, Texas, United States
• Research Site — Falls Church, Virginia, United States
• Research Site — Belo Horizonte, Brazil
• Research Site — Bragança Paulista, Brazil
• Research Site — Brasília, Brazil
• Research Site — Brasília, Brazil
• Research Site — Campina Grande do Sul, Brazil
• Research Site — Campinas, Brazil
• Research Site — Canoas, Brazil
• Research Site — Joinville, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Porto Alegre, Brazil
• Research Site — Ribeirão Preto, Brazil
• Research Site — Salvador, Brazil
• Research Site — Fairhope, Alabama, United States

Full record on ClinicalTrials.gov

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