Recruiting

Ondansetron

Sponsor:

Indiana University

Code:

NCT05844501

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ondansetron 8mg

Placebo

Study Details

Brief 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.

Conditions

Atrial Fibrillation

Study ID

NCT05844501

Start date

Apr 22, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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)
  • 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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ondansetron

Patients with atrial fibrillation scheduled to undergo AF ablation will receive treatment with ondansetron 8 mg orally twice daily for 28 days (n=40)

placebo comparator: Placebo

Patients with atrial fibrillation scheduled to undergo AF ablation will receive treatment with matching placebo orally twice daily for 28 days (n=40)

Interventions

Ondansetron 8mg

Ondansetron 8 mg orally twice daily for 28 days

Placebo

Matched placebo orally twice daily for 28 days

Primary outcome measure

  • Atrial fibrillation burden [ Time Frame: Total duration of study (28 days) ]
  • Ventricular rate control [ Time Frame: 7 days after initiation of ondansetron/placebo ]
  • Ventricular rate control [ Time Frame: 14 days after initiation of ondansetron/placebo ]
  • Ventricular rate control [ Time Frame: 21 days after initiation of ondansetron/placebo ]
  • Ventricular rate control [ Time Frame: 28 days after initiation of ondansetron/placebo ]

Central Contacts and Locations

Central contacts

James E Tisdale, PharmD

317-880-5418jtisdale@purdue.edu

Heather Jaynes, MSN

hwroblew@iu.edu

Locations

Indiana Clinical Research Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

James E Tisdale, BSC, PharmD

Purdue University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

James E Tisdale, BSc, PharmD

317-880-5418jtisdale@purdue.edu

Heather Jaynes, MSN

317-847-2094hwroblew@iu.edu

Principal Investigator:

James E Tisdale, BSc, PharmD

More Information

Sponsor

Indiana University

Last update posted

Feb 4, 2026

Last verified

Feb, 2026

Keywords

  • Randomized
  • Placebo-controlled
  • Ondansetron
  • Arrhythmias
  • Atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-02-04.