Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Atrial Fibrillation Clinical Trial

Official title:

Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818583
• Other study ID #: AK-01
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: November 2017

Study information

• Verified date: July 2018
• Source: Diakonhjemmet Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Atrial fibrillation is a condition in which the heart's upper chambers, the atria, contract at an abnormally rapid rate. It is a common type of arrhythmia, and occurs in 1-2% of the general population. The prevalence of atrial fibrillation increases with age. Between 50 and 70% of patients with atrial fibrillation lasting <48 hours spontaneously convert to normal sinus rhythm, and drug therapy increases the likelihood of conversion to sinus rhythm. Another treatment option for conversion of atrial fibrillation and atrial flutter is electrical conversion. This is an effective treatment but requires anesthesia.

Current treatment strategy for medical conversion of atrial fibrillation and atrial flutter is to employ drugs that affect ion channel activity in atrial cardiomyocytes. However, such converting drugs all have potentially serious side effects and are expensive. Potassium, sodium, calcium, and magnesium molecules are the most important ions causing electric current in the heart tissue. Our hypothesis is that hypokalemia promotes atrial fibrillation/atrial flutter by a direct effect on cardiomyocytes. Accordingly, we also hypothesize that potassium infusion may convert atrial fibrillation/atrial flutter to normal sinus rhythm. If so, this would be an inexpensive treatment with potentially very few side effects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours

• Plasma potassium =4,0 mmol/L.

• Age = 18 år

Exclusion Criteria:

• Plasma potassium > 4,0 mmol/L

• eGFR <30 mL/min

• Patients on antiarrhythmic therapy (flecainid, amiodarone, dronedarone or sotalol)

• Pregnancy

• Breast feeding

• Patients participating in a clinical trial during the last six months

• Addison disease, adynamia episodic hereditary, or Sickle cell anemia

• Metabolic acidosis, pH < 7,2

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• Potassium chloride

• Glucose 50 MG/ML

Locations

Country	Name	City	State
Norway	Diakonhjemmet Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Diakonhjemmet Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		During time of infusion
Primary	Cardioversion (time and percentage)		24 hours
Secondary	Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period.	The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.	At about 3 months follow up, plus additional 3 days ECG-monitoring