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Prevention study for Atrial Fibrillation
Official title Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
ClinicalTrials.gov ID: NCT06067438
What this study is testing
What is Amiodarone Hydrochloride?
Amiodarone Hydrochloride is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for atrial fibrillation.
Also referred to as Cordarone, Nexterone.
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
- This phase II trial studies how well amiodarone works in the prevention of atrial fibrillation (AF) after a minimally invasive esophagectomy (MIE) in patients with esophageal cancer. Atrial fibrillation (AF) is an irregular heart rhythm, usually associated with a rapid rate, that is caused by abnormal electrical activity within the atria.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients undergoing MIE will be evaluated for potential enrollment
- Indication of cancer, esophageal dysplasia or esophageal dysmotilities
- Age \> 18 years
- Ability to understand and the willingness to sign a written informed consent document
You likely can't join if
- History of chronic or paroxysmal AF, or atrial flutter
- Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
- Current preoperative use of amiodarone, as baseline home medication
- Development of AF intraoperatively
- Pregnancy
- Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
See the full eligibility criteria
- All patients undergoing MIE will be evaluated for potential enrollment
- Indication of cancer, esophageal dysplasia or esophageal dysmotilities
- Age \> 18 years
- Ability to understand and the willingness to sign a written informed consent document
- History of chronic or paroxysmal AF, or atrial flutter
- Previous severe adverse reaction or contraindication to amiodarone (e.g., pulmonary toxicity/fibrosis, hepatotoxicity, thyroid dysfunction)
- Current preoperative use of amiodarone, as baseline home medication
- Development of AF intraoperatively
- Pregnancy
- Negative pregnancy tests are required for participants of childbearing potential (PCBP) on Day of Surgery (DOS)
- Breastfeeding/chest feeding
- Aborted MIE operation
- QTcF (Fridericia formula) \> 500 for heart rate (HR) 60-100 within 30 days
- For patients with a heart rate (HR) of between 50-59 on their pre-operative screening electrocardiography (EKG), we will first review evidence of chronotropic cardiac response to exercise before inclusion in the study...
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, United States
Compensation & support
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, 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.