Could a common nausea drug tame a dangerous heart rhythm?
NCT ID NCT05844501
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether ondansetron, a drug usually used to prevent nausea from cancer treatment, can help people with atrial fibrillation (AFib). Researchers believe ondansetron may block a specific heart current that contributes to AFib. Eighty adults scheduled for AFib ablation will take either ondansetron or a placebo for 28 days to see if it reduces the time they spend in AFib and controls their heart rate.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ondansetron
- What this could lead to
- If it works, this could point toward a new, safer treatment for atrial fibrillation using a common anti-nausea drug.
- What could go wrong
- This is a small, early-phase trial with only 80 participants. Ondansetron is not yet proven for heart conditions, and the effect may be modest or absent.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana Clinical Research Center
RECRUITINGIndianapolis, Indiana, 46202, United States
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Indiana University Health Methodist Hospital
NOT_YET_RECRUITINGIndianapolis, Indiana, 46202, United States
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Purdue University
RECRUITINGIndianapolis, Indiana, 46202, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can exercise tame atrial fibrillation? trial tests workouts on heart rhythm and fitness
- Pacemaker lead position may cut heart rhythm complication
- Can zapping the heart beat drugs for AF in heart failure?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to quiet a racing heart: trial pits hybrid ablation against standard catheter treatment
- Stroke's hidden heart rhythm clue under investigation