drugset / Trial / NCT04676646
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2021-03-08
- Primary completion
- 2024-07-15
- Completion
- 2024-07-15
Outcome
Met primary endpoint
paper Higher percentage of SZC- vs placebo-treated participants had optimal response (71% vs 36%; OR: 4.45; 95% CI: 2.89-6.86; P < 0.001). PMID 39566872 ↗
Publications
- Kosiborod MN, Cherney DZI, Desai AS, Testani JM, Verma S, Chinnakondepalli K, Dolling D, Patel S, Dahl M, Eudicone JM, Friberg L, Ouwens M, Antunes MO, Connelly KA, Madrini V Jr, Kuthi L, Lala A, Lorenzo M, Guimaraes PO, Marcos MC, Merkely B, Nunez J, Squire I, Vaclavik J, Wranicz J, Petrie MC. Sodium Zirconium Cyclosilicate for Management of Hyperkalemia During Spironolactone Optimization in Patients With Heart Failure. J Am Coll Cardiol. 2025 Mar 18;85(10):971-984. doi: 10.1016/j.jacc.2024.11.014. Epub 2024 Nov 18.
- Kosiborod MN, Cherney D, Connelly K, Desai AS, Guimaraes PO, Kuthi L, Lala A, Madrini V Jr, Merkely B, Villota JN, Squire I, Testani JM, Vaclavik J, Verma S, Wranicz J, Dahl M, Eudicone JM, Friberg L, Petrie MC. Sodium Zirconium Cyclosilicate in HFrEF and Hyperkalemia: REALIZE-K Design and Baseline Characteristics. JACC Heart Fail. 2024 Oct;12(10):1707-1716. doi: 10.1016/j.jchf.2024.05.003. Epub 2024 May 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sodium Zirconium Cyclosilicate | Other / unclassified | 5 g | — |
| Subject | Sodium Zirconium Cyclosilicate | Other / unclassified | 10 g | — |
| Subject | Sodium Zirconium Cyclosilicate | Other / unclassified | 15 g | — |