A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: OHSU Knight Cancer Institute

This content was sourced from clinicaltrials.gov