RecruitingPhase 4NCT05844501

Ondansetron for the Management of Atrial Fibrillation

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


Sponsor

Indiana University

Enrollment

80 participants

Start Date

Apr 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

"Afib" is a common irregular heartbeat. Afib can cause stroke, blood clots, dementia and death. Medicines used to treat Afib often do not work well and can cause serious side effects. Clinicians need medicines that work better for Afib. Medicines for Afib work by blocking a current in the heart called a potassium current. There is a newer potassium current called IKas that can contribute to Afib. A medicine called ondansetron is used to keep people with cancer from getting sick to their stomach and throwing up. The investigators have found that ondansetron blocks IKas, and the investigators think that this means that ondansetron may work well to treat Afib. So, in this study the investigators want to find out if ondansetron can: 1) Reduce the amount of time that people have Afib, and 2) Slow down the heart rate when people have Afib. The investigators will study 80 people who are scheduled to have an AF ablation. Several weeks prior to undergoing the ablation procedure, these AF patients will be assigned by chance (like flipping a coin) to one of two groups: ondansetron 8 mg by mouth twice daily or a sugar pill (placebo), which they will take for 28 days. The people in the study will not know whether they are receiving ondansetron or placebo. The investigators will find out if ondansetron reduces the percentage of time that people are in Afib. Also, the investigators will find out if ondansetron slows the heart rate while people are having Afib. The investigators will compare the people in the study who take ondansetron with the people in the study who take placebo. This research will help the investigators to find out if ondansetron can be used as a medicine for people who have Afib.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests ondansetron — a drug commonly used to prevent nausea — as a potential treatment to reduce abnormal electrical activity in the heart during catheter ablation for atrial fibrillation (AF) or atrial flutter. Researchers believe ondansetron may help stabilize the heart rhythm during and after the procedure. **You may be eligible if...** - You are 18 to 100 years old - You have confirmed atrial fibrillation and/or atrial flutter on an ECG - You are scheduled for an elective catheter ablation procedure - You are receiving recommended blood-thinning medications as appropriate for your risk level **You may NOT be eligible if...** - You are a woman who could become pregnant - You have had unexplained fainting in the past 6 months - You have active hyperthyroidism (overactive thyroid) - Your atrial fibrillation was caused by a reversible non-cardiac condition - You have severely reduced heart pumping function or were recently hospitalized for worsening heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOndansetron 8mg

Ondansetron 8 mg orally twice daily for 28 days

DRUGPlacebo

Matched placebo orally twice daily for 28 days


Locations(3)

Indiana Clinical Research Center

Indianapolis, Indiana, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Purdue University

Indianapolis, Indiana, United States

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NCT05844501


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