Targeted potassium levels to decrease arrhythmia burden in high risk patients with cardiovascular diseases (POTCAST): Study protocol for a randomized controlled trial

Ulrik Winsløw*, Tharsika Sakthivel, Chaoqun Zheng, Helle Bosselmann, Ketil Haugan, Niels Bruun, Charlotte Larroudé, Kasper Iversen, Hillah Saffi, Emil Frandsen, Niels Risum, Henning Bundgaard, Christian Jøns

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftProtokolpeer review

Abstract

BACKGROUND: Low plasma potassium (p-K) is associated with increased risk of malignant arrhythmia and observational studies indicate protective effects of p-K in the upper reference level. However, randomized clinical studies are needed to document whether actively increasing p-K to high-normal levels is possible and safe and improves cardiovascular outcomes.

OBJECTIVE: To investigate if increased p-K reduces the risk of malignant arrhythmia and all-cause death in high-risk patients with a cardiovascular disease treated with an implantable cardioverter defibrillator (ICD) for primary or secondary preventive causes. Secondly, to investigate whether high-normal p-K levels can be safely reached and maintained using already available medications and potassium-rich dietary guidance.

METHODS: This is a prospective, randomized, and open-labelled study enrolling patient at high-risk of malignant arrhythmias. According to sample size calculations, 1,000 patients will be randomized 1:1 to either an investigational regiment that aims to increase and maintain p-K at high-normal levels (4.5-5.0 mmol/l) or to usual standard of care and followed for an expected four years. The trial will run until a total of 291 events have occurred providing an α=0.05 and 1-β=0.80. The composite primary endpoint includes ventricular tachycardia >125 bpm lasting >30 seconds, any appropriate ICD-therapy, and all-cause mortality. At present, 739 patients have been randomized.

CONCLUSIONS: We present the rationale for the design of the POTCAST trial. The inclusion was initiated 2019 and is expected to be finished 2022. The study will show if easily available treatments to increase p-K may be a new treatment modality to protect against malignant arrythmias.

OriginalsprogEngelsk
TidsskriftAmerican heart journal
DOI
StatusUdgivet, E-publikation før trykning - 11 jul. 2022

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Copyright © 2022. Published by Elsevier Inc.

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