Targeted Potassium Levels for Prevention of ICD Therapy

  • End date
    Feb 5, 2024
  • participants needed
  • sponsor
    Rigshospitalet, Denmark
Updated on 1 March 2022
implantable cardioverter-defibrillators
cardiac resynchronization therapy


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.


There is solid evidence that potassium-sparing drugs increase survival and ameliorates symptoms in heart failure patients and post-hoc studies have suggested that high-normal levels of blood potassium levels (p-K) markedly decreases the risk of malignant arrhythmias in cardiovascular patients.

This trial will randomize patients implanted with implantable cardioverter defibrillators (ICDs), who remain at high risk of life-threatening cardiac arrhythmias, to a standard therapy or standard therapy plus a regimen to keep high-normal p-K levels. The study will enroll 1,000 patients from the outpatient pacemaker clinics at Rigshospitalet and Gentofte hospital. Using a planned regime to increase p-K using inexpensive drugs and potassium supplements, the patients enrolled and followed with regular controls as well as continuous monitoring using existing home monitoring systems over a period of 4 years for the primary endpoint of appropriate ICD therapy and all cause mortality. Including analysis, the trial will be running for 5 years

Condition Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User, Hypokalemia, Hyperkalemia, Ventricular Tachycardia, Atrial Fibrillation
Treatment Targeted serum potassium level
Clinical Study IdentifierNCT03833089
SponsorRigshospitalet, Denmark
Last Modified on1 March 2022


Yes No Not Sure

Inclusion Criteria

Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemaker with ICD (CRT-D)
Age >18 years

Exclusion Criteria

Estimated glomerular filtration rate (eGFR) <30 ml/h
Lack of ability to understand and sign informed consent
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