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Serotonin 5-HT3 Receptor Antagonist

Ondansetron for Atrial Fibrillation

Phase 4
Recruiting
Led By James E Tisdale, PharmD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persistent ECG-verified AF requiring elective conversion to SR
Be older than 18 years old
Must not have
Diagnosis of active thyrotoxicosis
New York Heart Association class IV heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total duration of study (28 days)
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is studying whether ondansetron can help with Afib, a common irregular heartbeat that can cause stroke, blood clots, dementia and death. It will compare the effects of ondansetron to placebo in 80 people.

Who is the study for?
This trial is for men and women aged 18-100 with persistent atrial fibrillation (Afib) needing electric shock treatment, on recommended blood thinners unless exempt. Excluded are pregnant women, those with recent syncope or thyrotoxicosis, reversible noncardiac Afib causes, contraindicated anticoagulation use, recent heart surgery, certain drug therapies including serotonergic drugs and QTc-prolonging medications.
What is being tested?
The study tests if Ondansetron can stop Afib before scheduled electric shocks to restore normal rhythm or reduce its duration over a month. Participants will randomly receive either Ondansetron or a placebo without knowing which one they're taking. The effect on heart rate during Afib will also be observed.
What are the potential side effects?
Ondansetron may cause headaches, constipation or diarrhea, dizziness and fatigue. Rarely it might lead to serious effects like changes in heartbeat rhythm or allergic reactions in individuals sensitive to the medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a heart rhythm problem that needs treatment to correct it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with an overactive thyroid.
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I have the most severe form of heart failure.
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I have been diagnosed with low blood pressure.
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I am not taking any medications like SSRIs, MAOIs, or lithium.
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I have been diagnosed with worsening heart failure.
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I have had heart rhythm issues caused by medication.
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I have been diagnosed with phenylketonuria.
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I am currently taking both beta-blockers and a type of blood pressure medicine that is not a dihydropyridine.
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I have been diagnosed with congenital long QT syndrome.
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I have been diagnosed with Wolff-Parkinson-White syndrome.
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My heart's pumping ability is very weak.
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I am not taking any medications that can affect my heart's rhythm.
Select...
My AFib is caused by a temporary non-heart condition.
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I have fainted for no known reason in the last 6 months.
Select...
My liver disease is severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total duration of study (28 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and total duration of study (28 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Atrial fibrillation burden
Ventricular rate control
Secondary study objectives
Adverse effects
Proportion of patients in sinus rhythm
Time to atrial fibrillation recurrence

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OndansetronExperimental Treatment1 Intervention
Patients with atrial fibrillation scheduled to undergo AF ablation will receive treatment with ondansetron 8 mg orally twice daily for 28 days (n=40)
Group II: PlaceboPlacebo Group1 Intervention
Patients with atrial fibrillation scheduled to undergo AF ablation will receive treatment with matching placebo orally twice daily for 28 days (n=40)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ondansetron 8mg
2022
Completed Phase 4
~450

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,804 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
227 Patients Enrolled for Atrial Fibrillation
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,107 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
92,158 Patients Enrolled for Atrial Fibrillation
Purdue UniversityOTHER
233 Previous Clinical Trials
71,293 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
210 Patients Enrolled for Atrial Fibrillation
James E Tisdale, PharmDPrincipal InvestigatorPurdue University
6 Previous Clinical Trials
353 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
210 Patients Enrolled for Atrial Fibrillation

Media Library

Ondansetron (Serotonin 5-HT3 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05844501 — Phase 4
Atrial Fibrillation Research Study Groups: Ondansetron, Placebo
Atrial Fibrillation Clinical Trial 2023: Ondansetron Highlights & Side Effects. Trial Name: NCT05844501 — Phase 4
Ondansetron (Serotonin 5-HT3 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05844501 — Phase 4
~53 spots leftby Dec 2027
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