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Ondansetron for the Management of Atrial Fibrillation

StatusRecruiting
PhasePhase 4
Started2025-04-22
View on ClinicalTrials.gov ↗

Amendment history

2026-02-02
Study Status, Contacts/Locations v16
Study sitescontacts updated at 3 of 3 sites
2025-05-27
Study Status v15
Start dateestimated 2025-07-01→confirmed 2025-04-22
2025-03-28
Study Status v14
Start date2025-03-01→2025-07-01
2025-02-13
Study Status v13
Start date2025-01-15→2025-03-01
2024-11-22
Study Status v12
Start date2024-10-15→2025-01-15
Show 11 earlier versions
2024-09-13
Study Status v11
Start date2024-08-15→2024-10-15
2024-07-23
Study Status v10
Start date2024-07-01→2024-08-15
2024-06-25
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v9
Eligibility criteria-10 characters
Inclusion Criteria: Men and women 18-100 years of age Persistent ECG-verified AF and/or atrial flutter requiring elective conversioncatheter to SRablation Receiving guideline-recommended anticoagulation (if CHA2DS2 [...]
Study description+120 characters
[...] o-controlled study in patients with AF (n=80). Patients with persistent AF scheduled to undergo an elective directcatheter currentAF cardioversionablation (DCCpulmonary vein isolation) will be randomized in double-blind fashion to oralreceive ondansetron 8 mg twice daily (n=40) or matching placebo (n=40) for 28 days. The ondansetronstudy drug/placebo will be initiated withinseveral 7weeks prior to the ablation procedure, and the 28 days followingof treatment will be complete at least 3 days prior to the DCC procedureablation. Continuous ECG recording will be performed using 2 consecu [...]
Study sitescontacts updated at 3 of 3 sites
2024-06-13
Study Status v8
Start date2024-05-01→2024-07-01
2024-03-18
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v7
Eligibility criteria+274 characters
Inclusion Criteria: Men and women 18-100 years of age Persistent ECG-verified AF and/or atrial flutter requiring elective conversion to SR Receiving guideline-rec [...] New York Heart Association class IV heart failure Diagnosis ifof severe liver disease (Child-Pugh score greater than or equa [...] ockers and a nondihydropyridine CCB History of drug-induced TdPtorsades de pointes or QTc prolongation Concomitant therapy with QTc-prolonging medications (www.crediblemeds.org), except amiodarone and propafenone Concomitant therapy with serotonergic drugs (selective serot [...] orphine, phenytoin, carbamazepine, oxcarb [...]
Secondary endpoints4 to 3 entries
Time to conversion to sinus rhythm
Primary endpoints8 to 5 entries
ConversionVentricular torate sinus rhythmcontrol Ventricular rate control after day of scheduled electrical cardioversion Ventricular rate control after day of scheduled electrical cardioversion Ventricular rate control after day of scheduled electrical cardioversion Ventricular rate control after day of scheduled electrical cardioversion Ventricular rate control on day of scheduled electrical cardioversion Ventricular rate control prior to day of scheduled electrical cardioversion
Study description-457 characters
[...] Aim 1: Determine the efficacy and safety of ondansetron for conversion ofreducing AF to SRburden. This aim will be achieved via a prospective, randomized, d [...] tron 8 mg twice daily (n=40) or matching placebo (n=40) for 228 days. The ondansetron/placebo will be initiated within 7 days following the DCC procedure. Continuous ECG recording will be performed using 2 consecutive adhesive skin patch ECG monitors, which provide 14-days of continuous recording. The primary outcome measure will be proportion of patients who are in SR prior to scheduled DCC. Successful pharmacological cardioversion will be [...] [...]
2024-03-04
Study Status v6
Primary completion date2026-12→2027-12-31
Completion date2026-12→2027-12-31
Start date2024-01-22→2024-05-01
2024-01-03
Study Status v5
Start date2023-11-01→2024-01-22
2023-10-16
Study Status v4
Start date2023-10-01→2023-11-01
2023-09-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2023-09-18→2023-10-01
Study sitesdetails revised at 3 of 3 sites
2023-09-06
Study Status, Eligibility, Contacts/Locations, IPDSharing v2
Start date2023-08-21→2023-09-18
Eligibility criteria+41 characters
Inclusion Criteria: Men and women 18-85100 years of age Persistent ECG-verified AF requiring elective [...] orphine, phenytoin, carbamazepine, oxcarbazepine, rifampin. SubjectsPatients with pre-existing allergies to adhesives Patients with neuromuscular stimulators
Study sitescontacts updated at 1 of 3 sites
2023-07-28
Study Status v1
Start date2023-06→2023-08-21
2023-04-25
Original filing
"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.
Trial Details
NCT Number NCT05844501
Lead Sponsor Indiana University
Collaborators: American Heart Association, Purdue University
Conditions Atrial Fibrillation
Enrollment 80 participants
Start Date 2025-04-22
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-04