Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

NCT ID: NCT01818583

Last Updated: 2018-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-11-30

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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Potassium chloride

Intervention Type: DRUG

Placebo

5% glucose (flow rate 265 ml/h) as placebo infusion.

Group Type: PLACEBO_COMPARATOR

Glucose 50 MG/ML

Intervention Type: DRUG

Interventions

Potassium chloride

Intervention Type: DRUG

Glucose 50 MG/ML

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Diakonhjemmet Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kiarash Tazmini

Kiarash Tazmini, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erik Øie, MD, PhD

Role: STUDY_DIRECTOR

Diakonhjemmet Hospital

Locations

Diakonhjemmet Hospital

Oslo, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 31986288 (View on PubMed)

Other Identifiers

AK-01

Identifier Type: -

Identifier Source: org_study_id