Ondansetron for Atrial Fibrillation Study

This study is looking into whether ondansetron (a medicine often used to prevent nausea and vomiting in cancer patients) can help people with atrial fibrillation (Afib), which is a common irregular heartbeat. Researchers believe ondansetron might work by blocking a specific electrical current in the heart called IKas, which contributes to Afib. You might be able to join if you are between 18 and 100 years old, have Afib or atrial flutter that needs a procedure called catheter ablation, and are taking blood thinners if needed. The study will measure how much Afib you experience and how well your heart rate is controlled over 28 days. The current status of this study is unclear.

Study design
This is a randomized, double-blind study involving 80 participants. Participants will either receive ondansetron or a placebo.
What's involved
You would take ondansetron 8 mg or a matched placebo orally twice daily for 28 days.
Compensation
Not stated in the trial record.
Follow-up
Your atrial fibrillation burden will be measured over the total 28-day study duration. Ventricular rate control will be measured at 7 and 14 days after starting the study drug.

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NCT05844501

Ondansetron for the Management of Atrial Fibrillation

Recruiting
PHASE4Ages 18+InterventionalTreatment
Indiana University
~80 participants
Updated 2026-02-04 on ClinicalTrials.gov
What's tested:Ondansetron 8mgPlacebo

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Atrial fibrillation burden
Measured over Total duration of study (28 days)
+4 more outcomes measured
Atrial Fibrillation
3 sites across 1 states
Indiana3
  • James E Tisdale, PharmD · PRINCIPAL_INVESTIGATOR · Purdue University

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Eligibility criteria

Inclusion

Men and women 18-100 years of age
ECG-verified AF and/or atrial flutter requiring elective catheter ablation
Receiving guideline-recommended anticoagulation (if CHA2DS2-VASc score is 0 (men) or 1 (women), anticoagulation can be omitted)

Exclusion

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)
Pretreatment QRS \> 180 ms, QTc \> 450 ms within two weeks of screening visit
Heart rate \< 50 beats per minute in SR
Diagnosis of hypotension
Diagnosis of Wolff-Parkinson-White syndrome
Previous ondansetron hypersensitivity or serotonin syndrome
Diagnosis of phenylketonuria
Diagnosis of congenital long QT syndrome
Concomitant therapy with both beta-blockers and a nondihydropyridine CCB
History of drug-induced torsades de pointes or QTc prolongation
Concomitant therapy with QTc-prolonging medications (www.crediblemeds.org), except amiodarone and propafenone
Concomitant therapy with serotonergic drugs (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, mirtazapine, lithium, tramadol), apomorphine, phenytoin, carbamazepine, oxcarbazepine, rifampin.
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
  • Atrial fibrillation burdenTotal duration of study (28 days)

    Burden of atrial fibrillation, defined as overall percentage of time in atrial fibrillation.

  • Ventricular rate control7 days after initiation of ondansetron/placebo

    Maximum heart rate while in atrial fibrillation

  • Ventricular rate control14 days after initiation of ondansetron/placebo

    Maximum heart rate while in atrial fibrillation

  • Ventricular rate control21 days after initiation of ondansetron/placebo

    Maximum heart rate while in atrial fibrillation

  • Ventricular rate control28 days after initiation of ondansetron/placebo

    Maximum heart rate while in atrial fibrillation