Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT06067438
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amiodarone Hydrochloride — DRUG
    Given IV and via feeding tube
  • Saline — OTHER
    Given IV

Study Details

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.

Key Dates

Start date
Jun 21, 2024
Status verified
May 2026
Primary completion
Aug 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone [ Time Frame: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Stephanie Wood
[email protected]
503-494-6900
Stephanie Wood (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Atrial fibrillationEsophageal cancer
By specialty
CardiologyHeart diseaseOncologyGI oncology
By research site
OHSU Knight Cancer Institute· Portland, OR

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