80 Participants Needed

Ondansetron for Atrial Fibrillation

Recruiting at 2 trial locations
JE
TT
TS
Overseen ByTanner Sergesketter, BSN
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Indiana University
Must be taking: Anticoagulants
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ondansetron, a drug typically used to prevent nausea, can aid individuals with atrial fibrillation (Afib), a condition characterized by an irregular heartbeat. Researchers aim to determine if ondansetron can reduce the duration of Afib episodes and slow the heart rate during these episodes. Participants will be divided into two groups: one receiving ondansetron and the other receiving a placebo (a sugar pill) for comparison. This trial suits individuals with Afib who are scheduled for an ablation procedure and are already on blood thinners as recommended. As a Phase 4 trial, this research seeks to understand how an FDA-approved and effective treatment can further benefit patients with Afib.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on certain medications like QTc-prolonging drugs (except amiodarone and propafenone) or serotonergic drugs. It's best to discuss your current medications with the trial team to see if they are allowed.

What is the safety track record for ondansetron?

Research shows that ondansetron, a drug often used to prevent nausea and vomiting, can sometimes affect heart rhythm. Some reports have found that it can cause unusual changes in the heart's electrical activity, potentially leading to dangerous heart rhythms. For example, one case involved a person developing atrial fibrillation, an irregular heartbeat, after taking ondansetron.

On the positive side, other studies have found benefits. In one study with very sick patients, those who took ondansetron had lower death rates in the hospital compared to those who didn't take it. This suggests that while there are risks, ondansetron might be helpful in certain situations.

The FDA has approved ondansetron for treating nausea and vomiting, indicating it has been tested for safety in those cases. However, its use for atrial fibrillation is still under study, and possible heart-related side effects should be considered. Always consult a healthcare provider to understand the risks and benefits for specific health needs.12345

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for atrial fibrillation, which often include medications like beta-blockers, calcium channel blockers, and anticoagulants, ondansetron is unique because it's primarily known as an anti-nausea medication. Researchers are excited because ondansetron acts on serotonin receptors, which might help stabilize heart rhythms in a novel way. This approach could offer a new pathway for managing atrial fibrillation, potentially with fewer side effects than traditional drugs.

What evidence suggests that ondansetron might be an effective treatment for Afib?

This trial will compare the effects of ondansetron with a placebo in patients with atrial fibrillation scheduled for AF ablation. Research suggests that ondansetron might help manage atrial fibrillation (Afib), an irregular heartbeat. Studies have shown that ondansetron blocks a specific electrical signal in the heart, potentially involved in Afib. Blocking this signal could reduce the duration of Afib episodes and slow the heart rate during these episodes. While ondansetron primarily prevents nausea, recent findings indicate it could also benefit the heart. However, some reports mention that ondansetron might cause abnormal heart rhythms, so potential risks must be considered. Overall, evidence suggests ondansetron could be promising for treating Afib, but further research is needed.12356

Who Is on the Research Team?

JE

James E Tisdale, PharmD

Principal Investigator

Purdue University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a heart rhythm problem that needs treatment to correct it.
I am on blood thinners as recommended, unless my risk score allows skipping it.

Exclusion 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.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ondansetron 8 mg orally twice daily or placebo for 28 days

4 weeks
Continuous ECG monitoring with 2 visits for ECG patch application

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ondansetron
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: OndansetronExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Ondansetron is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Zofran for:
🇪🇺
Approved in European Union as Zofran for:
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Approved in Canada as Zofran for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

American Heart Association

Collaborator

Trials
352
Recruited
6,196,000+

Purdue University

Collaborator

Trials
239
Recruited
72,200+

Published Research Related to This Trial

Ondansetron is an effective antiemetic that works by selectively inhibiting the 5-HT3 serotonin receptor, showing equal or superior efficacy compared to the traditional antiemetic metoclopramide, especially against nausea from cisplatin and other highly emetogenic drugs.
It is generally well tolerated with few adverse effects, such as headache and gastrointestinal issues, and does not cause extrapyramidal reactions, making it a safe option for preventing nausea and vomiting during chemotherapy.
Ondansetron: a serotonin receptor (5-HT3) antagonist for antineoplastic chemotherapy-induced nausea and vomiting.Kohler, DR., Goldspiel, BR.[2019]
Ondansetron has been shown to be safe and well-tolerated in approximately 1,400 cancer patients and 650 other volunteers, with the main side effects being mild constipation and headache.
The drug has a wide therapeutic index, does not interact with commonly prescribed medications, and has no reported dependence or extrapyramidal side effects, making it a reliable option for anti-emetic treatment.
Safety of ondansetron.Smith, RN.[2013]
In a double-blind, placebo-controlled study of 20 patients with cerebellar tremor, ondansetron significantly improved performance on a writing task, with 13 out of 19 patients showing improvement compared to their baseline.
Patients also reported functional improvement in their tremor after receiving ondansetron, with 12 out of 20 feeling better, while none reported improvement with the placebo, indicating potential efficacy of ondansetron for tremor control.
Ondansetron, a 5-HT3 antagonist, improves cerebellar tremor.Rice, GP., Lesaux, J., Vandervoort, P., et al.[2019]

Citations

Ondansetron for the Management of Atrial FibrillationThe primary outcome measure will be AF burden (percentage of time in AF). Specific Aim 2: Determine the efficacy and safety of ondansetron for VR control in AF ...
Effects of ondansetron treatment on outcomes of critically ill ...Early use of OND in critically ill patients with MI may exert protective effects by reducing in-hospital mortality and 28- and 90-day mortality.
Abnormal heart rhythms may be associated with use of ...Ondansetron may increase the risk of developing abnormal changes in the electrical activity of the heart, which can result in a potentially fatal abnormal ...
Ondansetron for the Management of Atrial FibrillationThe investigators have found that ondansetron blocks IKas, and the investigators think that this means that ondansetron may work well to treat ...
Ondansetron-induced atrial fibrillation?We report a case in which new onset atrial fibrillation occurred possibly with the use of ondansetron in a 76 yr old male patient.
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/24314899/
Ondansetron and the risk of cardiac arrhythmiasEligible cases described a documented (or perceived) arrhythmia within 24 hours of ondansetron administration. The primary outcome was arrhythmia occurrence ...
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