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Targeted Potassium Levels for Prevention of ICD Therapy

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date: Apr 1, 2025 to May 9, 2025v6
  2. Primary endpoint revised
    • Primary completion date: Feb 1, 2025 to Apr 1, 2025
    • Study completion date: Feb 1, 2035 to Apr 1, 2035
    v5
  3. Primary completion date: Feb 5, 2023 to Feb 1, 2025v4 Show 7 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 1000 to 1200
    • Study sites: 2 to 3
    • Study completion date: Feb 5, 2024 to Feb 1, 2035
    • Start date: Apr 1, 2019 to Mar 1, 2019
    • Secondary endpoints: details revised at 7 of 7 entries
  4. Site details revised at 1 of 2 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of Feb 5, 2019 to Apr 1, 2019
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03833089
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Collaborators: Herlev and Gentofte Hospital
Conditions
(from sponsor)		 Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User, Hypokalemia, Hyperkalemia, Ventricular Tachycardia, Atrial Fibrillation
Related terms Atrial Fibrillation, Heart Arrest, Hyperkalemia, Hypokalemia, Tachycardia, Ventricular
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov