Clinical trial NCT03833089: Targeted Potassium Levels for Prevention of ICD Therapy
Official title: Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Ventricular Arrhythmias and Cardiac Arrest
Implantable Defibrillator User
Hypokalemia
Hyperkalemia
Ventricular Tachycardia
Atrial Fibrillation
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev and Gentofte Hospital
First posted: 2019-02-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Implantable cardioverter defibrillator (ICD) or cardiac resynchronization pacemaker with ICD (CRT-D).
* Age \>18 years

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \<30 ml/h
* Pregnancy
* Lack of ability to understand and sign informed consent

Primary outcomes:
measure: 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
timeFrame: Total 291 events, expected 6 years
Secondary outcomes:
measure: Time to first incidence of supraventricular arrhythmias as documented by ECG or the ICD
timeFrame: 6 years
measure: Proportion of patients experiencing <92 % CRT-pacing for > 2 weeks (only CRT-D patients)
timeFrame: 6 years
measure: Time to first hospitalization for heart failure
timeFrame: 6 years
measure: Time to first hospitalization for cardiac arrhythmias
timeFrame: 6 years
measure: Time to hospitalization for electrolyte disturbances or kidney failure
timeFrame: 6 years
measure: First occurrence of appropriate ICD therapy for ventricular tachycardia or ventricular fibrillation irrespective of outcome.
timeFrame: 6 years
measure: Time to first occurence of inappropriate ICD therapy
timeFrame: 6 years
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Gentofte University Hospital
state: Hellerup
city: Roskilde
country: Denmark
facility: Roskilde University Hospital
state: Region Zealand
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Dept of Cardiology, Rigshospitalet, Denmark
name: Christian Joens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept of Cardiology, Rigshospitalet, Denmark
name: Niels Risum, MD, PhD
role: STUDY_CHAIR
affiliation: Dept of Cardiology, Rigshospitalet, Denmark
name: Henning Bundgaard, Prof., DMSc
role: STUDY_CHAIR
References: