Targeted Potassium Levels for Prevention of ICD Therapy

Atrial Fibrillation Clinical Trial

Official title: Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

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

• NCT number: NCT03833089
• Study type: Interventional
• Source: Rigshospitalet, Denmark
• Contact: Christian Joens, MD, PhD
• Phone: +1-647-562-6151
• Email: Christian.joens.02@regionh.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Completion date: February 5, 2024