Actively Recruiting

Phase 4
Age: 18Years - 100Years
All Genders
NCT05844501

Ondansetron for the Management of Atrial Fibrillation

Led by Indiana University · Updated on 2026-02-04

80

Participants Needed

3

Research Sites

140 weeks

Total Duration

On this page

Sponsors

I

Indiana University

Lead Sponsor

A

American Heart Association

Collaborating Sponsor

AI-Summary

What this Trial Is About

"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.

CONDITIONS

Official Title

Ondansetron for the Management of Atrial Fibrillation

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women 18-100 years of age
  • ECG-verified atrial fibrillation or atrial flutter requiring elective catheter ablation
  • Receiving guideline-recommended anticoagulation (except if CHA2DS2-VASc score is 0 for men or 1 for women)
Not Eligible

You will not qualify if you...

  • Women of childbearing potential
  • Syncope of unknown origin within the previous 6 months
  • Active thyrotoxicosis diagnosis
  • Atrial fibrillation from reversible noncardiac causes
  • Acutely decompensated heart failure
  • Left ventricular ejection fraction less than or equal to 20%
  • New York Heart Association class IV heart failure
  • Severe liver disease (Child-Pugh score ≥ 10)
  • Cardiac surgery within the last 2 months
  • Contraindications to anticoagulation
  • Pretreatment QRS > 180 ms or QTc > 450 ms within two weeks of screening
  • Heart rate below 50 beats per minute in sinus rhythm
  • Hypotension diagnosis
  • Wolff-Parkinson-White syndrome
  • Previous ondansetron hypersensitivity or serotonin syndrome
  • Phenylketonuria diagnosis
  • Congenital long QT syndrome
  • Concomitant therapy with both beta-blockers and nondihydropyridine calcium channel blockers
  • History of drug-induced torsades de pointes or QTc prolongation
  • Use of QTc-prolonging medications except amiodarone and propafenone
  • Use of serotonergic drugs including SSRIs, SNRIs, MAO inhibitors, mirtazapine, lithium, tramadol, apomorphine, phenytoin, carbamazepine, oxcarbazepine, rifampin
  • Pre-existing allergies to adhesives
  • Presence of neuromuscular stimulators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Indiana Clinical Research Center

Indianapolis, Indiana, United States, 46202

Actively Recruiting

2

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

3

Purdue University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

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Research Team

J

James E Tisdale, PharmD

CONTACT

H

Heather Jaynes, MSN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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