Targeted Potassium Levels for Prevention of ICD Therapy

  • STATUS
    Recruiting
  • End date
    Feb 5, 2024
  • participants needed
    1000
  • sponsor
    Rigshospitalet, Denmark
Updated on 24 January 2021
Investigator
Christian Joens, MD, PhD
Primary Contact
Rigshospitalet (0.0 mi away) Contact
+1 other location
arrhythmia
potassium
implantable cardioverter-defibrillators
cardiac resynchronization therapy

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.

Description

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

Details
Condition Arrhythmia, Atrial Fibrillation, Hyperkalemia, Hypokalemia, Tachycardia, Ventricular tachycardia, Fast Heart Rate (Tachycardia), Implantable Defibrillator User, Atrial Fibrillation (Pediatric), Dysrhythmia, Ventricular Arrhythmias and Cardiac Arrest
Treatment Targeted serum potassium level
Clinical Study IdentifierNCT03833089
SponsorRigshospitalet, Denmark
Last Modified on24 January 2021

Eligibility

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
Pregnancy
Lack of ability to understand and sign informed consent
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