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Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Diakonhjemmet Hospital
Sponsor:
Information provided by (Responsible Party):
Kiarash Tazmini, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier:
NCT01818583
First received: March 22, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted

March 22, 2013
March 22, 2013
March 2013
June 2016   (final data collection date for primary outcome measure)
Cardioversion (time and percentage) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At 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 three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.
Same as current
Adverse events [ Time Frame: During time of infusion ] [ Designated as safety issue: Yes ]
Same as current
 
Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Atrial Flutter
  • Potassium
  • Cardioversion
Drug: Potassium chloride
  • Experimental: Potassium
    Potassium chloride infusion at a rate of 10 mmol/h (80 mmol KCl in 1000 ml of 5% glucose with a concentration of 0.08 mmol/mL, flow rate 125 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.
    Intervention: Drug: Potassium chloride
  • Placebo Comparator: Placebo
    5% glucose (flow rate 125 ml/h) as placebo infusion.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
218
June 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with paroxysmal atrial fibrillation/atrial flutter with duration <48 hours or <7 days and who are anticoagulated and have had INR >2 in >3 weeks
  • Serum potassium ≤4,0 mmol/L.
  • Age ≥ 18 år

Exclusion Criteria:

  • 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
Both
18 Years and older
No
Contact: Erik Øie, MD, PhD +47-22454055 erik.oie@diakonsyk.no
Contact: Kiarash Tazmini, MD +47-22451500 kiarash.tazmini@diakonsyk.no
Norway
 
NCT01818583
AK-01
Yes
Kiarash Tazmini, Diakonhjemmet Hospital
Diakonhjemmet Hospital
Not Provided
Study Director: Erik Øie, MD, PhD Diakonhjemmet Hospital
Diakonhjemmet Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP