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Targeted Potassium Levels for Prevention of ICD Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03833089
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Herlev and Gentofte Hospital
Information provided by (Responsible Party):
Christian Joens, Rigshospitalet, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Ventricular Arrhythmias and Cardiac Arrest Implantable Defibrillator User Hypokalemia Hyperkalemia Ventricular Tachycardia Atrial Fibrillation Combination Product: Targeted serum potassium level Phase 4

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels
Estimated Study Start Date : February 5, 2019
Estimated Primary Completion Date : February 5, 2023
Estimated Study Completion Date : February 5, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
No Intervention: Control
ICD recipients in optimal Medical treatment as per guidelines according to their comorbidity
Experimental: Targeted serum potassium levels
ICD recipients recipients in optimal Medical treatment as per guidelines according to their comorbidity. In addition to guideline recommended treatment, this cohort will be treated to increase serum potassium levels to 4.5-5.0 mEq/L.
Combination Product: Targeted serum potassium level
In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Potassium supplementation, 3) mineralocorticoid receptor antagonists,

Primary Outcome Measures :
  1. Time to first major event defined as a combination of: - first occurence of ECG documented ventricular tachycardia > 125 bpm lasting > 30 seconds - first occurence of any appropriate ICD therapy as documented by the ICD - All cause mortality [ Time Frame: 4 years ]

    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 Outcome Measures :
  1. Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD [ Time Frame: 4 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: 4 years ]
    CRT-D home monitoring systems allow temporal evaluation of percentage of CRT pacing.

  3. Time to first hospitalization for heart failure [ Time Frame: 4 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: 4 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: 4 years ]
  6. First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome. [ Time Frame: 4 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: 4 years ]
    Any cause of inappropriate shock including atrial fibrillation, other supraventricular arrhythmias, ICD lead problems etc.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03833089

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Contact: Christian Joens, MD, PhD +1-647-562-6151
Contact: Niels Risum, MD, PhD +4523456073

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Gentofte University Hospital Not yet recruiting
Gentofte, Hellerup, Denmark, 2900
Contact: Tommi B Lindhart, MD, PhD    38672276   
Contact: Kasper K Iversen, MD, DMSc    +4538686009   
Sponsors and Collaborators
Rigshospitalet, Denmark
Herlev and Gentofte Hospital
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Principal Investigator: Christian Joens, MD, PhD Dept of Cardiology, Rigshospitalet, Denmark
Study Chair: Niels Risum, MD, PhD Dept of Cardiology, Rigshospitalet, Denmark
Study Chair: Henning Bundgaard, Prof., DMSc Dept of Cardiology, Rigshospitalet, Denmark
  Study Documents (Full-Text)

Documents provided by Christian Joens, Rigshospitalet, Denmark:

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Responsible Party: Christian Joens, Staff Cardiologist, Electrophysiology, Principal investigator, PhD, Rigshospitalet, Denmark Identifier: NCT03833089     History of Changes
Other Study ID Numbers: 3589
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease
Water-Electrolyte Imbalance
Metabolic Diseases