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Atrial Fibrillation | Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Atrial Fibrillation research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Atrial Fibrillation

Atrial Flutter

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Potassium chloride

Drug:Glucose 50 MG/ML

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PotassiumPotassium 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.

Placebo5% glucose (flow rate 265 ml/h) as placebo infusion.

Study Status

Completed

Start Date: March 2013

Completed Date: November 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Cardioversion (time and percentage)

Secondary Outcome: Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period.

Study sponsors, principal investigator, and references

Principal Investigator: Erik Øie, MD, PhD

Lead Sponsor: Diakonhjemmet Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01818583

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