BridgeMD
New treatment option for Atrial Fibrillation
Official title Ondansetron for the Management of Atrial Fibrillation
ClinicalTrials.gov ID: NCT05844501
What this study is testing
What is Ondansetron 8mg?
Ondansetron 8mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- "Afib" is a common irregular heartbeat. Afib can cause stroke, blood clots, dementia and death.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join 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 likely can't join 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%
See the full eligibility criteria
- 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)
- 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
- Diagnosis of phenylketonuria
- Diagnosis of congenital long QT syndrome
- Concomitant therapy with both beta-blockers and a nondihydropyridine CCB
- History of drug-induced torsades de pointes or QTc prolongation
- Concomitant therapy with QTc-prolonging medications (www.crediblemeds.org), except amiodarone and propafenone
- Concomitant therapy with serotonergic drugs (selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, mirtazapine, lithium, tramadol), apomorphine...
- Left ventricular ejection fraction \< 20% and those with NYHA class IV heart failure with reduced ejection fraction (confirmed by diagnosis or echocardiogram within 6 months of enrollment in screening)
- Patients with pre-existing allergies to adhesives
- Patients with neuromuscular stimulators
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.