drugset / Trial / NCT03833089
Targeted Potassium Levels for Prevention of ICD Therapy
Phase 4
Active not recruiting
1200 enrolled
Rigshospitalet, Denmark
Herlev and Gentofte Hospital · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
This study evaluates whether a rigorously controlled high-normal level of serum-potassium (4.5-5.0 mEq/L) using dietary recommendations, potassium supplements and mineralocorticoid receptor antagonists will results in a lower incidence of cardiac arrhythmias in patients with an ICD. Patients will be randomized to this treatment or a control arm, where patients will receive usual guideline recommended follow-up.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2025-05-09
- Completion
- 2035-04-01
Outcome
Met primary endpoint
paper hazard ratio, 0.76; 95% confidence interval, 0.61 to 0.95; P = 0.01 PMID 40879429 ↗
Publications
- Sakthivel T, Winslow UC, Zheng C, Danielsen EM, Bosselmann HS, Vinther M, Bruun NE, Bundgaard H, Jons C, Risum N. Effects of plasma potassium on myocardial function: a POTCAST substudy. J Cardiovasc Imaging. 2026 Apr 2;34(1):7. doi: 10.1186/s44348-026-00068-7.
- Jons C, Zheng C, Winslow UCG, Danielsen EM, Sakthivel T, Frandsen EA, Saffi H, Vakilzadeh-Hashemi SS, Haugan KJ, Bruun NE, Iversen KK, Bosselmann HS, Risum N, Bundgaard H; POTCAST Study Group. Increasing the Potassium Level in Patients at High Risk for Ventricular Arrhythmias. N Engl J Med. 2025 Nov 20;393(20):1979-1989. doi: 10.1056/NEJMoa2509542. Epub 2025 Aug 29.
- Winslow U, Sakthivel T, Zheng C, Bosselmann H, Haugan K, Bruun N, Larroude C, Iversen K, Saffi H, Frandsen E, Oturai P, Jensen HJ, Vinther M, Risum N, Bundgaard H, Jons C. Treatment-induced increase in total body potassium in patients at high risk of ventricular arrhythmias; a randomized POTCAST substudy. PLoS One. 2023 Jul 19;18(7):e0288756. doi: 10.1371/journal.pone.0288756. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Potassium supplementation | Unknown | — | — |