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Atrial FibrillationPhase 2NCT06067438

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

A Phase 2 study testing Amiodarone Hydrochloride and Saline in people with Atrial Fibrillation and Esophageal Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Esophageal Carcinoma
What is being tested?
Amiodarone Hydrochloride and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteUnited States
Study dates
21 Jun 2024to 30 Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

    Stephanie Wood, 503-494-6900, woodste@ohsu.edu

    Stephanie Wood

    Recruiting

Other trials in United States

About this study

Official title: A Prospective, Randomized Controlled Trial Evaluating the Efficacy of Amiodarone in the Prevention of Postoperative Atrial Fibrillation in Patients Undergoing Minimally Invasive Esophagectomy

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the effect of prophylactic amiodarone on the rate of atrial fibrillation (AF) in patients undergoing minimally invasive esophagectomy (MIE).

SECONDARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Amiodarone Hydrochloride, Saline
Medical subject headings
Atrial Fibrillation, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Amiodarone HydrochlorideDrug

    Also called Cordarone, Nexterone

    Given IV and via feeding tube

  • SalineOther

    Also called ISOTONIC SODIUM CHLORIDE SOLUTION, Sodium Chloride 0.9%

    Given IV

Study groups in NCT06067438
Study groupRoleWhat they receive
Arm I (amiodarone hydrochloride)ExperimentalPatients receive amiodarone hydrochloride IV for 4 days and then via a feeding tube for 3 days on study.
Receives: Drug: Amiodarone Hydrochloride
Arm II (normal saline)Placebo comparatorPatients receive normal saline IV for 4 days on study.
Receives: Other: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Development of atrial fibrillation (AF), or completion of seven-day course of amiodarone

    Will be a binary variable (yes/no) and analyzed using a one-sided test of two proportions at an alpha level of 0.05.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone

Secondary outcomes (12)

  1. Postoperative (PostOp) rapid ventricular response

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% confidence interval (CI) of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital.

  2. Postop pulmonary complications

    Including pneumonia, acute respiratory distress syndrome, acute pulmonary edema, and chylothorax. Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

  3. Anastomotic leak

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

  4. ICU Readmission

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

  5. ICU length of stay (LOS)

    Will be assessed in days. Analysis: Wilcoxon rank sum test

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU

  6. Hospital LOS

    Will be assessed in days. Analysis: Wilcoxon rank sum test

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital

  7. 30 Day readmission rate

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: Day of discharge (DC) from hospital to 30 days after discharge

  8. Inpatient morality

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital

  9. Incidence of mortality within 30 days of surgery

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

  10. Incidence and type of adverse events

    Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30

  11. Time to AF

    Analysis: Log-rank test.

    Measured: From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7

  12. Serum amiodarone level, classified as therapeutic or subtherapeutic

    Measured: Post-operative day (POD) 2 to post-operative day (POD) 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start21 Jun 2024
  3. Primary completion30 Aug 2027 (estimated)
  4. Study completion30 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067438
Sponsor's protocol ID
STUDY00021572
Other IDs
NCI-2023-03642, STUDY00021572
Status last verified
May 2026
First submitted
1 Jun 2023
Last updated
22 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Amiodarone Hydrochloride and Saline in people with Atrial Fibrillation and Esophageal Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06067438.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.

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