Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Atrial Fibrillation
  • Hyperkalemia
  • Hypokalemia
  • Implantable Defibrillator User
  • Ventricular Arrhythmias and Cardiac Arrest
  • Ventricular Tachycardia
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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

Tracking Information

NCT #
NCT03833089
Collaborators
Herlev and Gentofte Hospital
Investigators
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