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Targeted Potassium Levels for Prevention of ICD Therapy

NCT03833089 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-05-09

No results posted yet for this 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.

Conditions

  • Ventricular Arrhythmias and Cardiac Arrest
  • Implantable Defibrillator User
  • Hypokalemia
  • Hyperkalemia
  • Ventricular Tachycardia
  • Atrial Fibrillation

Interventions

COMBINATION_PRODUCT

Targeted serum potassium level

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

Sponsors & Collaborators

  • Herlev and Gentofte Hospital

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Christian Joens, MD, PhD · Dept of Cardiology, Rigshospitalet, Denmark

  • Niels Risum, MD, PhD · Dept of Cardiology, Rigshospitalet, Denmark

  • Henning Bundgaard, Prof., DMSc · Dept of Cardiology, Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2025-05-09
Completion
2035-04-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03833089 on ClinicalTrials.gov