Atrial Fibrillation study: Amiodarone Hydrochloride vs Saline
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?
This is an investigational medicine being studied to see if it can help prevent atrial fibrillation after esophageal cancer surgery. It is designed to calm abnormal electrical signals in the heart to help maintain a steady rhythm.
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 study aims to find out if taking amiodarone after surgery lowers the chance of developing atrial fibrillation, a common irregular heart rhythm.
- Who it's for
- People with esophageal cancer who are scheduled to have minimally invasive surgery to remove part of their esophagus.
- What's involved
- Participants will be randomly assigned to either take amiodarone or a placebo (sugar pill) after their surgery. They will undergo standard post-surgical care and monitoring for heart rhythm issues.
- Time commitment
- The study involves taking daily medication and attending follow-up visits to monitor heart health after the surgery.
- 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 is enrolling
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.