Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Drug: Potassium chloride; Drug: Glucose 50 MG/ML

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0370
    • Diakonhjemmet Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Potassium; Potassium chloride infusion at a rate of 15 mmol/h (60 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.05 mmol/mL, flow rate 265 mL/h). If the serum Mg ≤0.8 mmol/L, MgSO4 infusion (0.5 mmol/kg/24 hours in 1000 mL NaCl 0.9% corresponding to an infusion rate of approximately 42 mL/hour) will also be administered.	Drug: Potassium chloride
Placebo Comparator: Placebo; 5% glucose (flow rate 265 ml/h) as placebo infusion.	Drug: Glucose 50 MG/ML

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardioversion (time and percentage)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	During time of infusion

Collaborators and Investigators

• Sponsor: Diakonhjemmet Hospital
• Investigators: Study Director: Erik Øie, MD, PhD, Diakonhjemmet Hospital

Publications and helpful links

General Publications

• Tazmini K, Fraz MSA, Nymo SH, Stokke MK, Louch WE, Oie E. Potassium infusion increases the likelihood of conversion of recent-onset atrial fibrillation-A single-blinded, randomized clinical trial. Am Heart J. 2020 Mar;221:114-124. doi: 10.1016/j.ahj.2019.12.014. Epub 2019 Dec 27.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: March 22, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 26, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2018
• Last Update Submitted That Met QC Criteria: July 29, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Potassium; Cardioversion; Atrial flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: AK-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No