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NCT05844501 · ClinicalTrials.gov registry record · Phase 4

Ondansetron for the Management of Atrial Fibrillation

A Phase 4 study of Atrial Fibrillation, sponsored by Indiana University.

Recruiting
Registry status
Phase 4
Development phase
80
Enrollment target
3
Study locations

NCT05844501 is a Phase 4 study of Atrial Fibrillation that is actively recruiting participants, run by Indiana University. The registered enrollment target is 80 participants, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 1 state.

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The verdict

NCT05844501, a Phase 4 study of Atrial Fibrillation, is actively recruiting participants, sponsored by Indiana University.

RECRUITING
Registry status
Phase 4
Development phase
80 participants
Enrollment target
3
Study locations

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG Ondansetron 8mg

Study Locations (3)

Indiana

  • Indiana Clinical Research Center - Indianapolis
  • Indiana University Health Methodist Hospital - Indianapolis
  • Purdue University - Indianapolis

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2025-04-22
Est. Completion 2027-12-31
Phase Phase 4

Sponsor

Indiana University

890 total trials

What the Registry Record Tells You About NCT05844501

The ClinicalTrials.gov registry entry for NCT05844501 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,997-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (97% lower). The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05844501 reports 3 study locations spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT05844501 about?

NCT05844501 is a clinical study titled "Ondansetron for the Management of Atrial Fibrillation". "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 call...

What is the current status of trial NCT05844501?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2025-04-22. Estimated completion is 2027-12-31.

What conditions does trial NCT05844501 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT05844501?

The interventions under investigation include: Placebo (DRUG), Ondansetron 8mg (DRUG).

Who is sponsoring clinical trial NCT05844501?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05844501 being conducted?

This trial has 3 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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