Ondansetron for Atrial Fibrillation
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ondansetron 8 mg orally twice daily or placebo for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ondansetron
- Placebo
Ondansetron is already approved in United States, European Union, Canada for the following indications:
- Prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy
- Prevention of postoperative nausea and/or vomiting
- Prevention of nausea and vomiting associated with chemotherapy
- Prevention of postoperative nausea and vomiting
- Prevention of nausea and vomiting associated with chemotherapy
- Prevention of postoperative nausea and vomiting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor
American Heart Association
Collaborator
Purdue University
Collaborator