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

NCT04676646

CompletedPhase 4

Sponsor: AstraZeneca

Conditions: Hyperkalaemia, Heart Failure With Reduced Ejection Fraction

Interventions: Sodium zirconium cyclosilicate, Placebo, Spironolactone

Countries: United States, Brazil, Canada, Czechia, Hungary, Poland, Spain, United Kingdom

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 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
Locations (89)
  • Fairhope, Alabama, United States
  • Los Angeles, California, United States
  • Torrance, California, United States
  • Evanston, Illinois, United States
  • Hazel Crest, Illinois, United States
  • Oak Lawn, Illinois, United States
  • Kansas City, Missouri, United States
  • New York, New York, United States
  • Winston-Salem, North Carolina, United States
  • Greenville, South Carolina, United States
  • Houston, Texas, United States
  • Falls Church, Virginia, United States
  • Belo Horizonte, Brazil
  • Bragança Paulista, Brazil
  • Brasília, Brazil
  • Brasília, Brazil
  • Campina Grande do Sul, Brazil
  • Campinas, Brazil
  • Canoas, Brazil
  • Joinville, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Ribeirão Preto, Brazil
  • Salvador, Brazil
  • Santa Cruz do Sul, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • + 59 more on CT.gov