RECRUITING

Ondansetron for the Management of Atrial Fibrillation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

"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.

Official Title

Inhibition of Small Conductance Calcium-Activated Potassium Current: A New Therapeutic Approach for Atrial Fibrillation

Quick Facts

Study Start:2025-01-15
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05844501

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women 18-100 years of age
  2. * ECG-verified AF and/or atrial flutter requiring elective catheter ablation
  3. * Receiving guideline-recommended anticoagulation (if CHA2DS2-VASc score is 0 (men) or 1 (women), anticoagulation can be omitted)
  1. * Women of childbearing potential
  2. * Subject reported syncope of unknown origin within the previous 6 months
  3. * Diagnosis of active thyrotoxicosis
  4. * Diagnosis AF from reversible noncardiac causes
  5. * Diagnosis of acutely decompensated heart failure
  6. * Left ventricular ejection fraction less than or equal to 20%
  7. * New York Heart Association class IV heart failure
  8. * Diagnosis of severe liver disease (Child-Pugh score greater than or equal to 10)
  9. * Cardiac surgery (preceding 2 months)
  10. * Not receiving anticoagulation due to contraindications (as determined by treating physician and recorded in the medical record)
  11. * Pretreatment QRS \> 180 ms, QTc \> 450 ms within two weeks of screening visit
  12. * Heart rate \< 50 beats per minute in SR
  13. * Diagnosis of hypotension
  14. * Diagnosis of Wolff-Parkinson-White syndrome
  15. * Previous ondansetron hypersensitivity or serotonin syndrome
  16. * Diagnosis of phenylketonuria
  17. * Diagnosis of congenital long QT syndrome
  18. * Concomitant therapy with both beta-blockers and a nondihydropyridine CCB
  19. * History of drug-induced torsades de pointes or QTc prolongation
  20. * Concomitant therapy with QTc-prolonging medications (www.crediblemeds.org), except amiodarone and propafenone
  21. * 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.
  22. * 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)
  23. * Patients with pre-existing allergies to adhesives
  24. * Patients with neuromuscular stimulators

Contacts and Locations

Study Contact

James E Tisdale, PharmD
CONTACT
317-880-5418
jtisdale@purdue.edu
Tanner Sergesketter, BSN
CONTACT
thom1277@purdue.edu

Principal Investigator

James E Tisdale, PharmD
PRINCIPAL_INVESTIGATOR
Purdue University

Study Locations (Sites)

Indiana Clinical Research Center
Indianapolis, Indiana, 46202
United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
United States
Purdue University
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • James E Tisdale, PharmD, PRINCIPAL_INVESTIGATOR, Purdue University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-15
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-01-15
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Randomized
  • Placebo-controlled
  • Ondansetron
  • Arrhythmias
  • Atrial fibrillation

Additional Relevant MeSH Terms

  • Atrial Fibrillation