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Trial Title:
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
NCT ID:
NCT06067438
Condition:
Atrial Fibrillation
Esophageal Carcinoma
Conditions: Official terms:
Esophageal Neoplasms
Atrial Fibrillation
Amiodarone
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Amiodarone Hydrochloride
Description:
Given IV and via feeding tube
Arm group label:
Arm I (amiodarone hydrochloride)
Other name:
Cordarone
Other name:
Nexterone
Intervention type:
Other
Intervention name:
Saline
Description:
Given IV
Arm group label:
Arm II (normal saline)
Other name:
ISOTONIC SODIUM CHLORIDE SOLUTION
Other name:
Sodium Chloride 0.9%
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.
Detailed description:
PRIMARY OBJECTIVE:
I. To evaluate the effect of prophylactic amiodarone on the rate of atrial fibrillation
(AF) in patients undergoing minimally invasive esophagectomy (MIE).
SECONDARY OBJECTIVES:
I. In each subobjective, below, evaluations of the effects of prophylactic amiodarone on
the following will be made:
- Ia. Postoperative (PostOp) rapid ventricular response;
- Ib. Postop pulmonary complications;
- Ic. Postop anastomotic leak;
- Id. Intensive care unit (ICU) readmission;
- Ie. ICU length of stay (LOS);
- If. Hospital LOS;
- Ig. 30-day readmission;
- Ih. Inpatient mortality;
- Ii. 30-day mortality;
- Ij. Adverse events;
- Ik. Time to AF;
Il. Evaluating the association between therapeutic (or serum levels and the development
of AF in the experimental group only.
EXPLORATORY OBJECTIVE:
I. To evaluate the effect of prophylactic amiodarone administration on hospital cost of
care.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive amiodarone hydrochloride intravenously (IV) for 4 days and then
via a feeding tube for 3 days in the absence of disease progression or unacceptable
toxicity.
ARM II: Patients receive placebo (normal saline) IV for 4 days in the absence of disease
progression or unacceptable toxicity.
Patients are followed for 60 days following discharge from hospitalization after MIE.
Criteria for eligibility:
Criteria:
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
- QTcB (Bazzett formula) > 500 for heart rate (HR) 60-100 within 30 days
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephanie Wood
Phone:
503-494-6900
Email:
woodste@ohsu.edu
Investigator:
Last name:
Stephanie Wood
Email:
Principal Investigator
Start date:
June 17, 2024
Completion date:
August 30, 2026
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06067438
