NCT06067438 Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer
| NCT ID | NCT06067438 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | OHSU Knight Cancer Institute |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-06-21 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2024-06-21 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * 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
Contact & Investigator
Stephanie Wood
PRINCIPAL INVESTIGATOR
OHSU Knight Cancer Institute
Frequently Asked Questions
Who can join the NCT06067438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06067438 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06067438 currently recruiting?
Yes, NCT06067438 is actively recruiting participants. Visit ClinicalTrials.gov or contact OHSU Knight Cancer Institute to inquire about joining.
Where is the NCT06067438 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06067438 clinical trial?
NCT06067438 is sponsored by OHSU Knight Cancer Institute. The principal investigator is Stephanie Wood at OHSU Knight Cancer Institute. The trial plans to enroll 90 participants.
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