Targeted Potassium Levels for Prevention of ICD Therapy

Rigshospitalet

Status and phase: Active, not recruiting; Phase 4

Conditions: Hyperkalemia; Atrial Fibrillation; Hypokalemia; Ventricular Arrhythmias and Cardiac Arrest; Implantable Defibrillator User; Ventricular Tachycardia

Treatments: Combination Product: Targeted serum potassium level

Study type: Interventional

Funder types: Other

Identifiers

NCT03833089

3589

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Control

No Intervention group

Description:

ICD recipients in optimal Medical treatment as per guidelines according to their comorbidity

Targeted serum potassium levels

Experimental group

Description:

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.

Treatment:

Combination Product: Targeted serum potassium level