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Could a common nausea drug tame a dangerous heart rhythm?

NCT ID NCT05844501

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

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

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.

Arrhythmias, Cardiac atrial fibrillation

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Indiana Clinical Research Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Indiana University Health Methodist Hospital

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Purdue University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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