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RECRUITING
NCT05844501
PHASE4

Ondansetron for the Management of Atrial Fibrillation

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-04-22

Completion Date

2027-12-31

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

DRUG

Ondansetron 8mg

Ondansetron 8 mg orally twice daily for 28 days

DRUG

Placebo

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