Recruiting
Phase 2

Amiodarone

Sponsor:

OHSU Knight Cancer Institute

Code:

NCT06067438

Conditions

Atrial Fibrillation

Esophageal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Amiodarone Hydrochloride

Saline

Study Details

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

Study ID

NCT06067438

Start date

Jun 21, 2024

Status verified date

May, 2026

Completion date

Aug 30, 2027

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (amiodarone hydrochloride)

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

placebo comparator: Arm II (normal saline)

Patients receive normal saline IV for 4 days on study.

Interventions

Amiodarone Hydrochloride

Given IV and via feeding tube

Saline

Given IV

Primary outcome measure

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

Central Contacts and Locations

Locations

OHSU Knight Cancer Institute

Recruiting

Portland, Oregon, United States, 97239

Contacts

Stephanie Wood

503-494-6900woodste@ohsu.edu

Principal Investigator:

Stephanie Wood

More Information

Sponsor

OHSU Knight Cancer Institute

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OHSU Knight Cancer Institute on 2026-05-22.