NCT05844501RecruitingPhase 4
Ondansetron for the Management of Atrial Fibrillation
Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 4 Feb 2026
Brief summary (registry, in English)
"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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 13 Apr 2023
- Start date
- Apr 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Indiana University
- Diseases
- Atrial fibrillation
- NCT number
- NCT05844501
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 80
- From Apr 2025 to the primary completion date, Dec 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject reported syncope of unknown origin within the previous 6 months
- Not receiving anticoagulation due to contraindications (as determined by treating physician and recorded in the medical record)
- Previous ondansetron hypersensitivity or serotonin syndrome
- Concomitant therapy with both beta-blockers and a nondihydropyridine CCB
- 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.
Other illness
- Diagnosis of acutely decompensated heart failure
- Cardiac surgery (preceding 2 months)
- Heart rate \< 50 beats per minute in SR
- Diagnosis of Wolff-Parkinson-White syndrome
- Patients with pre-existing allergies to adhesives
Lab values
- 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)
- Pretreatment QRS \> 180 ms, QTc \> 450 ms within two weeks of screening visit
- Diagnosis of congenital long QT syndrome
- History of drug-induced torsades de pointes or QTc prolongation
- Concomitant therapy with QTc-prolonging medications (www.crediblemeds.org), except amiodarone and propafenone
- 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)
Other
- Women of childbearing potential
- Diagnosis of active thyrotoxicosis
- Diagnosis AF from reversible noncardiac causes
- Diagnosis of hypotension
- Diagnosis of phenylketonuria
- Patients with neuromuscular stimulators
Who the study is looking for
- 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)
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Indiana Clinical Research Center Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| Indiana University Health Methodist Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Not yet recruiting |
| Purdue University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.