Clinical trial NCT01818583: Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Official title: Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Atrial fibrillation
Atrial flutter
Potassium
Cardioversion
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cardioversion (time and percentage)
timeFrame: 24 hours
Secondary outcomes:
measure: Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period.
timeFrame: At about 3 months follow up, plus additional 3 days ECG-monitoring
Other outcomes:
measure: Adverse events
timeFrame: During time of infusion
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Erik Øie, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.