Clinical trial NCT04392921: Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation
Official title: Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, single-centre, double arm pragmatic randomized controlled feasibility trial
Primary purpose: PREVENTION

Brief summary: After surgery on the lungs or esophagus, 12-46% of patients experience an irregular heart rhythm called atrial fibrillation. Although usually transient, post-operative atrial fibrillation is associated with longer stay in hospital, greater complications, and increased risk of death. Several medications have been shown to be effective at reducing the risk of atrial fibrillation after their surgery with the greatest effectiveness and safety demonstrated with amiodarone. Nevertheless, amiodarone has potential side effects, and so it is only recommended in patients with increased risk of developing atrial fibrillation. A tool has been developed and validated to identify high-risk patients but no clinical trial has looked at the effectiveness of administering amiodarone in this high-risk group. This study aims to assess the feasibility and safety of conducting a clinical trial where patients are randomized to receive amiodarone or placebo. This is critical before considering a full-scale trial to assess the effectiveness of amiodarone in reducing atrial fibrillation after surgery on the lungs or esophagus.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or greater
* Undergoing major non-cardiac pulmonary or esophageal surgery (including esophagectomy, pulmonary wedge resection, lobar resection, pneumonectomy, or gastrectomy)
* POAF prediction score greater than or equal to 4

Exclusion Criteria:

* Aged less than 18 years
* History of atrial arrhythmia (paroxysmal or persistent), or Wolf-Parkinson-White syndrome (WPW), or 2nd or 3rd degree heart block without a pacemaker
* Current antiarrythmic therapy (including amiodarone, propafenone, sotalol, flecainide, and dronedarone)
* Previous severe adverse reaction or contraindication to amiodarone (including pre-existing interstitial lung disease, or history of hepatotoxicity from amiodarone)
* QTc interval longer than 450ms
* Serum alanine transaminase or aspartate transaminase over 3 times the upper limit of normal, or Child-Pugh class C
* Allergy to amiodarone

Primary outcomes:
measure: Capability for enrolment
timeFrame: Upon study completion, 1 year following study initiation
measure: Proportion of patients randomized who receive the intervention
timeFrame: Upon study completion, 1 year following study initiation
measure: Knowledge of which patients received intervention and placebo
timeFrame: Upon study completion, 1 year following study initiation
measure: Intervention delivery
timeFrame: Upon study completion, 1 year following study initiation
measure: Protocol compliance
timeFrame: Upon study completion, 1 year following study initiation
measure: Adherence to safety protocol
timeFrame: Upon study completion, 1 year following study initiation
measure: Proportion of patients for which data could be abstracted
timeFrame: Upon study completion, 1 year following study initiation
measure: Resources
timeFrame: Upon study completion, 1 year following study initiation
Secondary outcomes:
measure: Incidence of postoperative atrial fibrillation
timeFrame: Within 30 days post-surgery
measure: Severity of postoperative atrial fibrillation
timeFrame: Within 30 days post-surgery
measure: Hospital length of stay
timeFrame: Within 30 days post-surgery
measure: Other postoperative complications
timeFrame: Within 30 days post-surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Andrew JE Seely, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith HA, Kanji S, Tran DTT, Redpath C, Ferguson D, Lenet T, Sigler G, Gilbert S, Maziak D, Villeneuve P, Sundaresan S, Seely AJE. Prophylaxis for patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF trial): a protocol for a feasibility randomized controlled study. Trials. 2021 Jun 7;22(1):384. doi: 10.1186/s13063-021-05318-1.