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Active, Not Recruiting

NCT Number: NCT03833089

Targeted Potassium Levels for Prevention of ICD 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ventricular Arrhythmias and Cardiac Arrest Arrhythmias, Cardiac Atrial Fibrillation Cardiac Conduction System Disease Cardiovascular Diseases Heart Arrest Heart Diseases Hyperkalemia Hypokalemia Implantable Defibrillator User Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular Ventricular Tachycardia Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gentofte University Hospital, Gentofte Municipality, Hellerup, Denmark

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted serum potassium level

Combination Product

In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Mineralocorticoid receptor antagonists, 3) Potassium supplementation,

Primary outcomes

  1. Time to first occurrence of ECG documented ventricular tachycardia, appropriate ICD therapy, hospitalization > 24 hours due to arrhythmias and/or heart failure leading to a change in treatment and all cause mortality

    Time frame: Total 291 events, expected 6 years

    A combination of:

    • ECG documented ventricular tachycardia > 125 bpm lasting > 30 seconds
    • Any appropriate ICD therapy as documented by the ICD or ECG
    • Any unplanned hospitalizations > 24 hours due to arrhythmias and/or heart failure leading to a change in treatment, e.g., administration of new drugs, or change in doses of already prescribed drugs or invasive or non-invasive treatment.
    • All-cause mortality

    The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient.

    ECG documented tachycardia from ECGs or ICD interrogations will be obtained from hospitalizations or outpatients clinic visits via electronic records after patient consent. Information of ventricular tachyarrhythmia therapy will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits.

    Mortality will be obtained from danish electronic hospital files or the danish death registry.

Secondary outcomes

  1. Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD

    Time frame: 6 years

    Any supraventricular tahcycardia documented on ECG, telemetry or as monitored/treated event on the ICD

  2. Proportion of patients experiencing <92 % CRT-pacing for > 2 weeks (only CRT-D patients)

    Time frame: 6 years

    CRT-D home monitoring systems allow temporal evaluation of percentage of CRT pacing.

  3. Time to first hospitalization for heart failure

    Time frame: 6 years

    Hospitalization with symptoms of heart failure and with a diagnosis of heart failure where treatment with i.v. diuretics was initiated.

  4. Time to first hospitalization for cardiac arrhythmias

    Time frame: 6 years

    Hospitalization were records indicate that supraventricular or ventricular arrhythmias were implicated in the cause of the hospitalization

  5. Time to hospitalization for electrolyte disturbances or kidney failure

    Time frame: 6 years

    Hospitalization were records indicate that kidney failure or disturbances in the potassium or sodium plasma leves were implicated in the cause of the hospitalization

  6. First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome.

    Time frame: 6 years

    Ventricular tachy-arrhythmia therapy, which will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits. All ICD therapy is routinely adjudicated as appropriate or in-appropriate by electrophysiologists at the study sites.

  7. Time to first occurence of inappropriate ICD therapy

    Time frame: 6 years

    Any cause of inappropriate shock including atrial fibrillation, other supraventricular arrhythmias, ICD lead problems etc.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Herlev and Gentofte Hospital

Registry information

Official study title

Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels

Important dates

Study start
2019
Primary completion
2025
Study completion
2035
First posted
Feb 6, 2019
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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