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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter|
- Cardioversion (time and percentage) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At about 3 months follow up, plus additional 3 days ECG-monitoring ] [ Designated as safety issue: No ]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.
- Adverse events [ Time Frame: During time of infusion ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818583
|Contact: Erik Øie, MD, PhDfirstname.lastname@example.org|
|Contact: Kiarash Tazmini, MDemail@example.com|
|Oslo, Norway, 0370|
|Contact: Erik Øie, MD, PhD +47-22454055 firstname.lastname@example.org|
|Contact: Kiarash Tazmini, MD +47-22451500 email@example.com|
|Principal Investigator: Kiarash Tazmini, MD|
|Study Director:||Erik Øie, MD, PhD||Diakonhjemmet Hospital|