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Amiodarone for Preventing Atrial Fibrillation After Esophageal Cancer Surgery

This study is looking at whether the medication amiodarone can prevent an irregular heartbeat called atrial fibrillation (AF) after surgery for esophageal cancer. AF is a common heart complication after a minimally invasive esophagectomy (MIE), which is a surgery to remove part of the esophagus. Currently, there are no standard guidelines for using medications like amiodarone to prevent AF after this surgery. This study will compare amiodarone to a placebo (saline) in about 90 patients aged 18 and older who are having MIE for esophageal cancer. The main goal is to see if amiodarone reduces the chance of developing AF within seven days after starting the medication.

Study design
This is an interventional study that will randomize about 90 participants to receive either amiodarone or saline. The phase of the study is not specified.
What's involved
Participants will receive amiodarone or saline intravenously (IV) for 4 days, then amiodarone via a feeding tube for 3 days. They will be followed for 60 days after leaving the hospital.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 60 days after discharge from the hospital following their surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06067438

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

Recruiting
PHASE2Ages 18+InterventionalSupportive care
OHSU Knight Cancer Institute
~90 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Amiodarone HydrochlorideSaline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone
Measured over From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone

Conditions

Atrial Fibrillation
Esophageal Carcinoma

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NCT06067438

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OHSU Knight Cancer Institute

    Portland, Oregonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephanie Wood · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Who to contact

Stephanie Wood
[email protected]
503-494-6900
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Development of atrial fibrillation (AF), or completion of seven-day course of amiodaroneFrom initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone

    Will be a binary variable (yes/no) and analyzed using a one-sided test of two proportions at an alpha level of 0.05.