Clinical trial · Interventional
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. AF is the most common complication after MIE for esophageal cancer. There has never been a study of AF after MIE that has used unbiased assignment of patients to receive preventative amiodarone or not. Further, there is no standard recommendation or guideline for preventative medications, such as amiodarone, to decrease the risk of AF in patients having MIE performed for cancer. In fact, most medical centers in the United States and around the world do not give preventative amiodarone after esophagectomy. Giving amiodarone after MIE surgery may be able to reduce the risk of AF for patients with esophageal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
| Esophageal Carcinoma | Esophageal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amiodarone Hydrochloride | Drug | — | UNRESOLVED |
| Saline | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (amiodarone hydrochloride)
- description
- Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study.
- interventionNames
- Drug: Amiodarone Hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Arm II (normal saline)
- description
- Patients receive normal saline IV for 4 days on study.
- interventionNames
- Other: Saline
Primary outcomes (1)
- measure
- Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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