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

NCT06067438 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: STUDY00021572NCI-2023-03642
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Atrial Fibrillation; Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Development of atrial fibrillation (AF), or completion of seven-day course of 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.

  From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone

Secondary Outcomes (12)

• Postoperative (PostOp) rapid ventricular response

  From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital.

• Postop pulmonary complications

  From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

• Anastomotic leak

  From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

• ICU Readmission

  From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

• ICU length of stay (LOS)

  From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU

Study Arms (2)

Arm I (amiodarone hydrochloride)

EXPERIMENTAL

Patients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study.

Drug: Amiodarone Hydrochloride

Arm II (normal saline)

PLACEBO COMPARATOR

Patients receive normal saline IV for 4 days on study.

Other: Saline

Interventions

Amiodarone Hydrochloride DRUG

Given IV and via feeding tube

Also known as: Cordarone, Nexterone

Arm I (amiodarone hydrochloride)

Saline OTHER

Given IV

Also known as: ISOTONIC SODIUM CHLORIDE SOLUTION, Sodium Chloride 0.9%

Arm II (normal saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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)
• Breastfeeding/chest feeding
• Aborted MIE operation
• QTcF (Fridericia formula) \> 500 for heart rate (HR) 60-100 within 30 days

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Esophageal Neoplasms

Interventions

Amiodarone; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Stephanie Wood

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: October 4, 2023
• Study Start: June 21, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)