Targeted Potassium Levels for Prevention of ICD Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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,

Study 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.

Eligibility

Primary outcome measure(s)

• Time to first occurrence of ECG documented ventricular tachycardia, appropriate ICD therapy, hospitalization > 24 hours due to arrhythmias and/or heart failure leading to a change in treatment and all cause mortality — Total 291 events, expected 6 years
  A combination of: * ECG documented ventricular tachycardia \> 125 bpm lasting \> 30 seconds * Any appropriate ICD therapy as documented by the ICD or ECG * Any unplanned hospitalizations \> 24 hours due to arrhythmias and/or heart failure leading to a change in treatment, e.g., administration of new drugs, or change in doses of already prescribed drugs or invasive or non-invasive treatment. * All-cause mortality The time period with regards to the Time-to-Event Outcome Measures starts with the randomization of the patient. ECG documented tachycardia from ECGs or ICD interrogations will be obtained from hospitalizations or outpatients clinic visits via electronic records after patient consent. Information of ventricular tachyarrhythmia therapy will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits. Mortality will be obtained from danish electronic hospital files or the danish death registry.

Trial sites (3)

More Copenhagen University Hospital, Rigshospitalet trials in Denmark

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