Trial record 2 of 45 for:    Open Studies | "Potassium"

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
  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
Potassium
Cardioversion
Drug: Potassium chloride
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Diakonhjemmet Hospital:

Primary Outcome Measures:
  • Cardioversion (time and percentage) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • Adverse events [ Time Frame: During time of infusion ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 218
Study Start Date: March 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Potassium chloride
Placebo Comparator: Placebo
5% glucose (flow rate 125 ml/h) as placebo infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kiarash Tazmini, Kiarash Tazmini, MD, Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT01818583     History of Changes
Other Study ID Numbers: AK-01
Study First Received: March 22, 2013
Last Updated: March 22, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Diakonhjemmet Hospital:
Atrial fibrillation
Atrial flutter
Potassium
Cardioversion

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

ClinicalTrials.gov processed this record on July 23, 2014