Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Launched by OHSU KNIGHT CANCER INSTITUTE · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring whether a medication called amiodarone can help prevent a common heart problem known as atrial fibrillation (AF) in patients who have esophageal cancer and are undergoing a specific type of surgery called minimally invasive esophagectomy (MIE). Atrial fibrillation is an irregular heartbeat that can occur after this surgery, and while amiodarone is used for other heart issues, there hasn’t been much research on its use for preventing AF in patients after MIE. This study is important because many hospitals do not currently use amiodarone for this purpose, and the researchers want to see if it can effectively reduce the risk of AF.

To be eligible for this trial, participants must be at least 18 years old and scheduled for MIE due to esophageal cancer or related issues. However, people with a history of AF, certain health conditions, or those who are pregnant or breastfeeding cannot join. If you participate, you will receive either amiodarone or a placebo (a dummy treatment) to see how well it works in preventing AF after surgery. This trial is currently recruiting participants, and anyone considering joining should feel comfortable asking questions and discussing their options with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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. If a patient's HR increases to ≥ 100 with exercise, the patient is eligible for inclusion of study. Exercise testing options may include a stair climb, a brisk walk, or supine leg-lifts prior to surgery. If exercise is not an option, we can review results of formal stress testing chronotropic response (ie. HR ≥ 100). HR monitoring can be collected by either pulse oximeter or EKG