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Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

This study is currently recruiting participants.
Verified December 2016 by Kiarash Tazmini, Diakonhjemmet Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01818583
First Posted: March 26, 2013
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kiarash Tazmini, Diakonhjemmet Hospital
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation Atrial Flutter Drug: Potassium chloride Drug: Glucose 50 MG/ML Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter

Resource links provided by NLM:


Further study details as provided by Kiarash Tazmini, Diakonhjemmet Hospital:

Primary Outcome Measures:
  • Cardioversion (time and percentage) [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Atrial fibrillation at 3 months follow up visit and during 72 hours ECG-monitoring period. [ Time Frame: At about 3 months follow up, plus additional 3 days ECG-monitoring ]
    The patients will be followed up with a resting ECG about three months after study intervention, and subsequently on-demand ECG will be monitored for 72 hours.


Other Outcome Measures:
  • Adverse events [ Time Frame: During time of infusion ]

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Potassium chloride
Placebo Comparator: Placebo
5% glucose (flow rate 265 ml/h) as placebo infusion.
Drug: Glucose 50 MG/ML

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818583


Contacts
Contact: Erik Øie, MD, PhD +47-22454055 erik.oie@diakonsyk.no
Contact: Kiarash Tazmini, MD +47-22451500 kiarash.tazmini@diakonsyk.no

Locations
Norway
Diakonhjemmet Hospital Recruiting
Oslo, Norway, 0370
Contact: Erik Øie, MD, PhD    +47-22454055    erik.oie@diakonsyk.no   
Contact: Kiarash Tazmini, MD    +47-22451500    kiarash.tazmini@diakonsyk.no   
Principal Investigator: Kiarash Tazmini, MD         
Sponsors and Collaborators
Diakonhjemmet Hospital
Investigators
Study Director: Erik Øie, MD, PhD Diakonhjemmet Hospital
  More Information

Responsible Party: Kiarash Tazmini, Kiarash Tazmini, MD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01818583     History of Changes
Other Study ID Numbers: AK-01
First Submitted: March 22, 2013
First Posted: March 26, 2013
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kiarash Tazmini, Diakonhjemmet Hospital:
Atrial fibrillation
Atrial flutter
Potassium
Cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes


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