Atrial Fibrillation Clinical Trial
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
Verified date | June 2024 |
Source | OHSU Knight Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 30, 2025 |
Est. primary completion date | August 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 - QTcB (Bazzett formula) > 500 for heart rate (HR) 60-100 within 30 days |
Country | Name | City | State |
---|---|---|---|
United States | OHSU Knight Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
OHSU Knight Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7, after last dose of enteral amiodarone | |
Secondary | 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. | From initiation of amiodarone in the intensive care unit (ICU) to discharge (DC) from hospital. | |
Secondary | 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. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30 | |
Secondary | Anastomotic leak | Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30 | |
Secondary | ICU Readmission | Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30 | |
Secondary | ICU length of stay (LOS) | Will be assessed in days. Analysis: Wilcoxon rank sum test | From initiation of amiodarone in the intensive care unit (ICU) to time patient is moved out of ICU | |
Secondary | Hospital LOS | Will be assessed in days. Analysis: Wilcoxon rank sum test | From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital | |
Secondary | 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. | Day of discharge (DC) from hospital to 30 days after discharge | |
Secondary | Inpatient morality | Will be a binary value (yes/no). Analysis: Binomial test; point estimate and 95% CI of the difference between the two proportions. | From initiation of amiodarone in the intensive care unit (ICU) to time of discharge from hospital | |
Secondary | 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. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30 | |
Secondary | 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. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 30 | |
Secondary | Time to AF | Analysis: Log-rank test. | From initiation of amiodarone in the intensive care unit (ICU) to post-operative day (POD) 7 | |
Secondary | Serum amiodarone level, classified as therapeutic or subtherapeutic | Post-operative day (POD) 2 to post-operative day (POD) 3 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
Terminated |
NCT04115735 -
His Bundle Recording From Subclavian Vein
|
||
Completed |
NCT04571385 -
A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)
|
Phase 2 | |
Completed |
NCT05366803 -
Women's Health Initiative Silent Atrial Fibrillation Recording Study
|
N/A | |
Completed |
NCT02864758 -
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
|
||
Recruiting |
NCT05442203 -
Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease
|
N/A | |
Completed |
NCT05599308 -
Evaluation of Blood Pressure Monitor With AFib Screening Feature
|
N/A | |
Completed |
NCT03790917 -
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
|
||
Enrolling by invitation |
NCT05890274 -
Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO
|
N/A | |
Recruiting |
NCT05266144 -
Atrial Fibrillation Patients Treated With Catheter Ablation
|
||
Recruiting |
NCT05316870 -
Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation
|
N/A | |
Not yet recruiting |
NCT06023784 -
The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block
|
N/A | |
Recruiting |
NCT05572814 -
Transform: Teaching, Technology, and Teams
|
N/A | |
Recruiting |
NCT04092985 -
Smart Watch iECG for the Detection of Cardiac Arrhythmias
|
||
Completed |
NCT04087122 -
Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures
|
N/A | |
Completed |
NCT06283654 -
Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
|
||
Recruiting |
NCT05416086 -
iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study
|
N/A | |
Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
Completed |
NCT04546763 -
Study Watch AF Detection At Home
|
||
Completed |
NCT03761394 -
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
|
N/A |