Status:
RECRUITING
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Conditions:
Atrial Fibrillation
Esophageal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 fibrillati...
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: ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06067438
Start Date
June 21 2024
End Date
August 30 2026
Last Update
September 23 2025
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239