Targeted Potassium Levels for Prevention of ICD Therapy

Atrial Fibrillation Clinical Trial

Official title:

Arrhythmia Prevention in High Risk Cardiovascular Patients Using Targeted Potassium Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03833089
• Other study ID #: 3589
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: February 5, 2024

Study information

• Verified date: October 2021
• Source: Rigshospitalet, Denmark
• Contact: Christian Joens, MD, PhD
• Phone: +1-647-562-6151
• Email: Christian.joens.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Hyperkalemia
• Hypokalemia
• Implantable Defibrillator User
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrhythmias and Cardiac Arrest
• Ventricular Tachycardia

Intervention

Combination Product:
• Targeted serum potassium level
In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Potassium supplementation, 3) mineralocorticoid receptor antagonists,

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Gentofte University Hospital	Gentofte	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first major event defined as a combination of: - first occurence of ECG documented ventricular tachycardia > 125 bpm lasting > 30 seconds - first occurence of any appropriate ICD therapy as documented by the ICD - 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.	4 years
Secondary	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	4 years
Secondary	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.	4 years
Secondary	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.	4 years
Secondary	Time to first hospitalization for cardiac arrhythmias	Hospitalization were records indicate that supraventricular or ventricular arrhythmias were implicated in the cause of the hospitalization	4 years
Secondary	Time to hospitalization for electrolyte disturbances or kidney failure		4 years
Secondary	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.	4 years
Secondary	Time to first occurence of inappropriate ICD therapy	Any cause of inappropriate shock including atrial fibrillation, other supraventricular arrhythmias, ICD lead problems etc.	4 years