Ondansetron for the Management of Atrial Fibrillation

NCT05844501 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 1658122TPA964193
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

"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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Atrial fibrillation burden

  Burden of atrial fibrillation, defined as overall percentage of time in atrial fibrillation.

  Total duration of study (28 days)

• Ventricular rate control

  Maximum heart rate while in atrial fibrillation

  7 days after initiation of ondansetron/placebo

• Ventricular rate control

  Maximum heart rate while in atrial fibrillation

  14 days after initiation of ondansetron/placebo

• Ventricular rate control

  Maximum heart rate while in atrial fibrillation

  21 days after initiation of ondansetron/placebo

• Ventricular rate control

  Maximum heart rate while in atrial fibrillation

  28 days after initiation of ondansetron/placebo

Secondary Outcomes (3)

• Proportion of patients in sinus rhythm

  28 days after initiation of ondansetron/placebo

• Time to atrial fibrillation recurrence

  28 days after scheduled electrical cardioversion

• Adverse effects

  During the 28 days of treatment with ondansetron or placebo

Study Arms (2)

Ondansetron

EXPERIMENTAL

Patients with atrial fibrillation scheduled to undergo AF ablation will receive treatment with ondansetron 8 mg orally twice daily for 28 days (n=40)

Drug: Ondansetron 8mg

Placebo

PLACEBO COMPARATOR

Patients with atrial fibrillation scheduled to undergo AF ablation will receive treatment with matching placebo orally twice daily for 28 days (n=40)

Drug: Placebo

Interventions

Placebo DRUG

Matched placebo orally twice daily for 28 days

Placebo

Ondansetron 8mg DRUG

Ondansetron 8 mg orally twice daily for 28 days

Ondansetron

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Purdue University: collaborator
• American Heart Association: collaborator

Study Sites (3)

Indiana Clinical Research Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

Purdue University

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• James E Tisdale, PharmD

  Purdue University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James E Tisdale, PharmD

CONTACT

317-880-5418; jtisdale@purdue.edu

Heather Jaynes, MSN

CONTACT

hwroblew@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 6, 2023
• Study Start: April 22, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will become available upon publication of study results in clinical trials.gov. Data will be available indefinitely

Locations

US (3)