NCT05844501 Ondansetron for the Management of Atrial Fibrillation
| NCT ID | NCT05844501 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Indiana University |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2025-04-22 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
James E Tisdale, PharmD
PRINCIPAL INVESTIGATOR
Purdue University
Frequently Asked Questions
Who can join the NCT05844501 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05844501 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05844501 currently recruiting?
Yes, NCT05844501 is actively recruiting participants. Contact the research team at jtisdale@purdue.edu for enrollment information.
Where is the NCT05844501 trial being conducted?
This trial is being conducted at Indianapolis, United States, Indianapolis, United States, Indianapolis, United States.
Who is sponsoring the NCT05844501 clinical trial?
NCT05844501 is sponsored by Indiana University. The principal investigator is James E Tisdale, PharmD at Purdue University. The trial plans to enroll 80 participants.
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