Targeted Potassium Levels for Prevention of ICD Therapy

Last updated: May 8, 2025
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Not Recruiting

Phase

4

Condition

Heart Disease

Arrhythmia

Chest Pain

Treatment

Targeted serum potassium level

Clinical Study ID

NCT03833089
3589
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemakerwith ICD (CRT-D).

  • Age >18 years

Exclusion

Exclusion Criteria:

  • Estimated glomerular filtration rate (eGFR) <30 ml/h

  • Pregnancy

  • Lack of ability to understand and sign informed consent

Study Design

Total Participants: 1200
Treatment Group(s): 1
Primary Treatment: Targeted serum potassium level
Phase: 4
Study Start date:
March 01, 2019
Estimated Completion Date:
April 01, 2035

Study 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

Connect with a study center

  • Gentofte University Hospital

    Gentofte, Hellerup 2900
    Denmark

    Site Not Available

  • Roskilde University Hospital

    Roskilde, Region Zealand 4000
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

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