Heart failure & cardiomyopathies
Sodium Zirconium Cyclosilicate in Heart Failure and Reduced Ejection Fraction (HFrEF) and Hyperkalemia: REALIZE-K Design and Baseline Characteristics
Authors' conclusion
REALIZE-K is the first trial to evaluate whether SZC can enable rapid and safe MRA optimization and long-term continuation in patients with HFrEF and prevalent/high risk of hyperkalemia.
Study context
- Population
- HFrEF (NYHA II–IV; LVEF ≤40%) on optimal therapy except MRA, with prevalent hyperkalemia or at high risk; normokalemic on spironolactone ≥25 mg daily after run-inrun-in
- Participants
- 365 participants
- Comparison
- Continuing sodium zirconium cyclosilicate (SZC) vs placebo
- Primary endpoint
- Optimal response: normokalemia, on spironolactone ≥25 mg daily, no rescue for hyperkalemia
- Follow-up
- Months 1-6
Methodological detailsprospective, double-blind, placebo-controlled, open-label run-in, randomized withdrawal design (run-in responders randomized), baseline report (no outcome results)
- Prospective
- Double-blind
- Placebo-controlled
- Open-label run-in
- Randomized withdrawal design (run-in responders randomized)
- Baseline report (no outcome results)
Further findings
Baseline characteristics (randomized)
- Mean age
- 70 years
- eGFR <60 mL/min/1.73 m²
- 78%
- AF/flutter
- 38%
- Median NT-proBNP
- 1,136 pg/mL
- Sacubitril/valsartan
- 64%
- Beta-blocker
- 96%
- SGLT2 inhibitor
- 42%
- On spironolactone 50 mg daily at randomization
- 78%
Original publication
Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia: REALIZE-K Design and Baseline Characteristics. JACC Heart Fail. Published 13 May 2024. doi:10.
Summarised from the published abstract; every number is checked against it