drugset / Trial / NCT03833089

Targeted Potassium Levels for Prevention of ICD Therapy

NCT03833089 ↗

Phase 4 Active not recruiting 1200 enrolled Rigshospitalet, Denmark Herlev and Gentofte Hospital · collab
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

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

Outcome

Met primary endpoint

paper hazard ratio, 0.76; 95% confidence interval, 0.61 to 0.95; P = 0.01 PMID 40879429 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Potassium supplementation Unknown — —