Using ondansetron to manage atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Indiana Clinical Research Center
  Indianapolis, Indiana, United States Recruiting
• Purdue University
  Indianapolis, Indiana, United States Recruiting
• Indiana University Health Methodist Hospital
  Indianapolis, Indiana, United States Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

• 4D intracardiac echocardiography to guide left atrial appendage occlusion procedures

  A new 4D ICE catheter is being tested alongside standard imaging to see if it can safely guide left atrial appendage occlusion procedures for adults with atrial fibrillation.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07806890

• Thoracoscopic vs Catheter Ablation as the First Rhythm Control in Atrial Fibrillation with a Large Left Atrium

  This trial tests whether thoracoscopic surgical ablation is better at keeping atrial fibrillation under control than catheter ablation in people with persistent AF and a large left atrium who have not had an ablation before.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07783984

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.