NCT03833089

Targeted Potassium Levels for Prevention of ICD Therapy

Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
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,

Timeline

• Start date: 2019-03-01
• Primary completion: 2025-05-09
• Completion: 2035-04-01
• First posted: 2019-02-06
• Last updated: 2025-05-09

Locations

3 sites across 1 country: Denmark