A Phase 4 interventional study of Targeted serum potassium level in Ventricular Arrhythmias and Cardiac Arrest, Implantable Defibrillator User and Hypokalemia, sponsored by Rigshospitalet, Denmark. Active, not recruiting at 3 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-09.
Sponsored by Rigshospitalet, Denmark · Phase 4, Interventional, and Prevention
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
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 100 across 518 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ICD recipients in optimal Medical treatment as per guidelines according to their comorbidity
ICD recipients recipients in optimal Medical treatment as per guidelines according to their comorbidity. In addition to guideline recommended treatment, this cohort will be treated to increase serum potassium levels to 4.5-5.0 mEq/L.
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,
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
PDFs hosted by the registry, ClinicalTrials.gov.
Started Mar 2019 (actual). Primary completion is estimated for May 2025, 74 months after the start.
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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