Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

NCT01818583 | Completed Phase 4 DMC

• 1 other identifier: AK-01
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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

Keywords

Atrial fibrillation; Atrial flutter; Potassium; Cardioversion

Outcome Measures

Primary Outcomes (1)

• Cardioversion (time and percentage)

  24 hours

Secondary Outcomes (1)

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

  At about 3 months follow up, plus additional 3 days ECG-monitoring

Other Outcomes (1)

• Adverse events

  During time of infusion

Study Arms (2)

Potassium

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Glucose 50 MG/ML

Interventions

Potassium chloride DRUG

Potassium

Glucose 50 MG/ML DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with paroxysmal atrial fibrillation/atrial flutter with duration \<48 hours
• Plasma potassium ≤4,0 mmol/L.
• Age ≥ 18 år

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead

Study Sites (1)

Diakonhjemmet Hospital

Oslo, 0370, Norway

Location

Related Publications (1)

• 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.

  PMID: 31986288 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Potassium Chloride; Glucose

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Potassium Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Erik Øie, MD, PhD

  Diakonhjemmet Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kiarash Tazmini, MD

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: March 26, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 31, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)