Targeted Potassium Levels for Prevention of ICD Therapy
Last updated on July 2021Recruitment
- 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