Prophylaxis for Patients at Risk to Eliminate Post-operative Atrial Fibrillation (PREP-AF)

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Drug: Amiodarone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04392921

20190583-01H

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Description:

Patients randomized to amiodarone treatment

Treatment:

Drug: Amiodarone

Control Arm

Placebo Comparator group

Description:

Patients randomized to placebo treatment

Treatment:

Drug: Placebo