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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,200
In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Mineralocorticoid receptor antagonists, 3) Potassium supplementation,
Gentofte University Hospital
Gentofte Municipality, Hellerup, Denmark
Roskilde University Hospital
Roskilde, Region Sjælland, Denmark
Rigshospitalet
Copenhagen, Denmark
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
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.
Time frame: Total 291 events, expected 6 years
Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD
Any supraventricular tahcycardia documented on ECG, telemetry or as monitored/treated event on the ICD
Time frame: 6 years
Proportion of patients experiencing <92 % CRT-pacing for > 2 weeks (only CRT-D patients)
CRT-D home monitoring systems allow temporal evaluation of percentage of CRT pacing.
Time frame: 6 years
Time to first hospitalization for heart failure
Hospitalization with symptoms of heart failure and with a diagnosis of heart failure where treatment with i.v. diuretics was initiated.
Time frame: 6 years
Time to first hospitalization for cardiac arrhythmias
Hospitalization were records indicate that supraventricular or ventricular arrhythmias were implicated in the cause of the hospitalization
Time frame: 6 years
Time to hospitalization for electrolyte disturbances or kidney failure
Hospitalization were records indicate that kidney failure or disturbances in the potassium or sodium plasma leves were implicated in the cause of the hospitalization
Time frame: 6 years
First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome.
Ventricular tachy-arrhythmia therapy, which will be obtained from home monitoring systems or interrogation of the ICD devices during in-clinic visits. All ICD therapy is routinely adjudicated as appropriate or in-appropriate by electrophysiologists at the study sites.
Time frame: 6 years
Time to first occurence of inappropriate ICD therapy
Any cause of inappropriate shock including atrial fibrillation, other supraventricular arrhythmias, ICD lead problems etc.
Time frame: 6 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.