Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation

J
James Tisdale

Primary Investigator

Recruiting
18 years - 100 years
All
Phase N/A
80 participants needed
1 Location

Brief description of study

What is the purpose of this study?
Atrial fibrillation/ atrial flutter are common irregular heart beats or arrhythmias that causes quivering of the heart and sometimes a very fast heart rate and can lead to blood clots and strokes.  Many of the current drugs on the market used to treat atrial fibrillation are often ineffective and are associated with side effects effects. Ondansetron (Zofran) is a drug that is currently available on the market for the treatment of nausea and vomiting, but it also affects cells that control the heart rhythm and therefore, and may be effective for rhythm and rate control in AFib/flutter.
 
 

Detailed description of study

What will happen during the study?

  • Take either Zofran (ondansetron) 8 mg twice daily or matching placebo for 28 days.  
  • Wear a Ziopatch Continuous ECG monitor skin patch ECG monitors, on your chest for 28 days.
  • Complete 4 study visits lasting about 30 minutes each (can be home visits or at the clinical research center at IUHealth University Hospital)
  • During each visit your heart beat and rhythm will be measured using an ECG and on the second visit you will have a blood draw

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Atrial Fibrillation
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:
 

  •     Men and women 18-100 years of age
  •   Persistent or Paroxysmal Atrial Fibrillation and/or atrial flutter scheduled to undergo or have recently undergone a cardioversion or catheter ablation
  •   Persistent or Paroxysmal Atrial Fibrillation and/or atrial flutter receiving anti-arrhythmia treatment
  •   Receiving guideline-recommended anticoagulation


Exclusion Criteria:
 

  •     Women of childbearing potential
  •   Subject reported syncope of unknown origin within the previous 6 months
  •   Diagnosis of active thyrotoxicosis
  •   Diagnosis AF from reversible noncardiac causes
  •   Diagnosis of acutely decompensated heart failure
  •   Left ventricular ejection fraction less than or equal to 20%
  •       New York Heart Association class IV heart failure
  •       Diagnosis of severe liver disease (Child-Pugh score greater than or equal to 10)
  •   Cardiac surgery (preceding 2 months)
  •   Not receiving anticoagulation due to contraindications (as determined by treating physician and recorded in the medical record
  •   Diagnosis of hypotension
  •   Diagnosis of Wolff-Parkinson-White syndrome
  •   Previous zofran hypersensitivity or serotonin syndrome
  •   Diagnosis of phenylketonuria
  •   Diagnosis of congenital long QT syndrome
  •   History of drug-induced torsades de pointes or QTc prolongation
  •   Left ventricular ejection fraction < 20% and those with NYHA class IV heart failure with reduced ejection fraction (confirmed by diagnosis or echocardiogram within 6 months of enrollment in screening)
  •   Patients with pre-existing allergies to adhesives
  •   Patients with neuromuscular stimulators

Updated on 10 Jun 2025. Study ID: KIC-IIR-AFIB, 16581

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