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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total duration of study (28 days)
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have a heart rhythm problem that needs treatment to correct it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ total duration of study (28 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total duration of study (28 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Atrial fibrillation burden
Ventricular rate control
Secondary outcome measures
Adverse effects
Proportion of patients in sinus rhythm
Time to atrial fibrillation recurrence
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OndansetronExperimental Treatment1 Intervention
Patients with atrial fibrillation scheduled for electrical conversion to sinus rhythm 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 for electrical conversion to sinus rhythm 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
980 Previous Clinical Trials
981,682 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
241 Patients Enrolled for Atrial Fibrillation
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,546 Total Patients Enrolled
11 Trials studying Atrial Fibrillation
92,257 Patients Enrolled for Atrial Fibrillation
Purdue UniversityOTHER
224 Previous Clinical Trials
72,684 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
210 Patients Enrolled for Atrial Fibrillation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with an overactive thyroid.I have the most severe form of heart failure.I have been diagnosed with low blood pressure.I am not taking any medications like SSRIs, MAOIs, or lithium.I have been diagnosed with worsening heart failure.I have not had heart surgery in the last 2 months.I have had heart rhythm issues caused by medication.You have had a bad reaction to ondansetron before, or have had serotonin syndrome.I have a heart rhythm problem that needs treatment to correct it.I am not on blood thinners due to my doctor's advice.Your heart beats slower than 50 times per minute when it's in a regular rhythm.I have been diagnosed with phenylketonuria.I am currently taking both beta-blockers and a type of blood pressure medicine that is not a dihydropyridine.I have been diagnosed with congenital long QT syndrome.Your heart's electrical activity (QRS) is longer than 180 milliseconds, or your heart's rhythm (QTc) is longer than 450 milliseconds in the past two weeks.I am between 18 and 100 years old.I have been diagnosed with Wolff-Parkinson-White syndrome.My heart's pumping ability is very weak.I am not taking any medications that can affect my heart's rhythm.My AFib is caused by a temporary non-heart condition.I am on blood thinners as recommended, unless my risk score allows skipping it.I am a woman who could become pregnant.I have fainted for no known reason in the last 6 months.My liver disease is severe.You have had allergic reactions to adhesive materials in the past.You have a neuromuscular stimulator.
Research Study Groups:
This trial has the following groups:- Group 1: Ondansetron
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants of any age being admitted for this research project?
"This trial is open to adults aged between 18 and 85 years old."
Answered by AI
Has the FDA sanctioned Ondansetron for public use?
"Ondansetron has been approved by various regulatory bodies, thus it receives a score of 3 on our safety scale."
Answered by AI
Who has the potential to meet the requirements for participation in this clinical experiment?
"Those eligible to participate in this clinical trial must meet the age criteria of 18-85 and have been diagnosed with atrial fibrillation. A maximum of 80 participants are being accepted into this study."
Answered by AI
Is this investigation currently recruiting participants?
"According to the records on clinicaltrials.gov, this research is no longer actively recruiting participants - it was initially posted June 1st 2023 and last updated April 25th 2023. In spite of that, 496 other medical trials are currently open for enrolment."
Answered by AI
What are the primary objectives of this experimental endeavor?
"The primary objective of this clinical research is to evaluate the impact of ondansetron or placebo on atrial fibrillation burden over a two-day time frame. Secondary goals include gauging time to atrial fibrillation recurrence, measuring the proportion of patients in sinus rhythm 28 days after electrical cardioversion and assessing any adverse effects related to the drug or its placebo."
Answered by AI
Who else is applying?
What site did they apply to?
Indiana Clinical Research Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
What questions have other patients asked about this trial?
How long is the trial? What are the inclusion criteria?
PatientReceived 2+ prior treatments
Why did patients apply to this trial?
I have tried 5+ drugs that were either ineffective or significant side effects. Still seeking a medication that will help long term.
PatientReceived 1 prior treatment
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