Using ondansetron to manage atrial fibrillation
Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation
PHASE4 · Indiana University · NCT05844501
This study is testing if ondansetron, a medication usually used for nausea, can help people with atrial fibrillation feel better and manage their heart rate during treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 3 sites (Indianapolis, Indiana and 2 other locations) |
| Trial ID | NCT05844501 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of ondansetron, a medication typically used to prevent nausea, in reducing the burden of atrial fibrillation (AF) and controlling heart rate. The study will involve 80 patients scheduled for elective catheter ablation for AF, who will be randomly assigned to receive either ondansetron or a placebo for 28 days. The primary goals are to assess the effectiveness and safety of ondansetron in managing AF symptoms and improving patient outcomes. The trial is designed as a double-blind, placebo-controlled study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-100 with ECG-verified atrial fibrillation or atrial flutter who are scheduled for elective catheter ablation.
Not a fit: Patients with certain conditions such as severe heart failure, active thyrotoxicosis, or those not receiving anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a safer and more effective option for managing atrial fibrillation.
How similar studies have performed: While ondansetron is primarily known for its antiemetic properties, this approach to treating atrial fibrillation is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana and 2 other locations
- Indiana Clinical Research Center — Indianapolis, Indiana, United States (RECRUITING)
- Indiana University Health Methodist Hospital — Indianapolis, Indiana, United States (NOT_YET_RECRUITING)
- Purdue University — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: James E Tisdale, PharmD — Purdue University
- Study coordinator: James E Tisdale, PharmD
- Email: jtisdale@purdue.edu
- Phone: 317-880-5418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Atrial Fibrillation, Randomized, Placebo-controlled, Ondansetron, Arrhythmias, Atrial fibrillation