Using amiodarone to prevent atrial fibrillation after esophageal cancer surgery
A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy
This study is testing if the heart medication amiodarone can help prevent atrial fibrillation in patients recovering from esophageal cancer surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OHSU Knight Cancer Institute Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06067438 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of amiodarone in preventing atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE) for esophageal cancer. Patients will be randomly assigned to receive either amiodarone or a placebo following their surgery. The study aims to evaluate not only the incidence of AF but also other postoperative complications and overall hospital costs associated with the treatment. Participants will be monitored for 60 days post-discharge to assess outcomes related to AF and other health metrics.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are scheduled for minimally invasive esophagectomy due to esophageal cancer or related conditions.
Not a fit: Patients with a history of atrial fibrillation or those who have contraindications to amiodarone will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of atrial fibrillation in patients undergoing surgery for esophageal cancer.
How similar studies have performed: While there is limited research on the use of amiodarone specifically for this purpose, similar studies have shown promise in preventing AF in other surgical contexts.
Eligibility criteria
Show full inclusion / exclusion 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 * 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
Where this trial is running
Portland, Oregon
- OHSU Knight Cancer Institute — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Wood — OHSU Knight Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.