NCT04788186

Beta Blocker De-prescription Following Coronary Artery Bypass Graft Surgery (BEEFBURGER Trial).

BEta Blocker dEprescription Following Coronary Artery Bypass Graft sURGERy: Feasibility and Safety Pilot (BEEFBURGER Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Beta-blockers have the greatest cardiovascular impact in patients with reduced heart function/heart failure and in reducing the peri-operative risk of atrial fibrillation. In patients without these high-risk features treated with coronary artery bypass graft (CABG) surgery, their continued long-term role is unclear.

Detailed description

This is an open-label, non-inferiority, randomized comparison of beta-blocker continuation versus de-prescription at the 6-8 week follow-up following isolated and uncomplicated CABG at Royal University Hospital, Saskatoon. Patients treated with isolated CABG (without valve repair/replacement) and discharged on a beta-blocker are eligible for recruitment if they have preserved systolic function (EF ≥45%) and no history of heart failure, atrial fibrillation/flutter, or an alternate compelling indication for beta-blocker therapy. After obtaining informed consent, eligible patients are randomly assigned at 6-8 weeks to one of the two treatment groups: continued beta-blocker therapy per their usual clinical care OR beta-blocker de-prescription as per the study protocol. The primary objective of this study is to demonstrate recruitment feasibility for beta-blocker de-prescription 6-8 weeks following uncomplicated CABG. Exploratory outcomes include the composite of all-cause mortality, myocardial infarction, stroke, arrhythmia, and cardiovascular-related hospitalization (congestive heart failure, recurrent ischemia, arrhythmia \[supraventricular including atrial fibrillation, and ventricular\], syncope or need for pacemaker) over a 3-year follow up duration. Other exploratory outcomes will include a change in the patient reported quality of life using the Short Form (SF) 36 and Euro Qol (EQ) 5D questionnaires and angina score using the Seattle Angina Questionnaire (SAQ).

Conditions

• Coronary Artery Disease
• Acute Myocardial Infarction
• Coronary Artery Stenosis
• ST Elevation Myocardial Infarction
• Non-ST Elevation Myocardial Infarction (NSTEMI)

Interventions

Type	Name	Description
DRUG	De-prescribe beta blocker therapy	Participants will be de-prescribed for beta-blocker therapy. De-prescription will be performed as follows: * Half of pre-randomization dose for the first 3 days, then * Half of the above dose for the next 3 days, then discontinue

Timeline

• Start date: 2021-08-23
• Primary completion: 2024-08-31
• Completion: 2025-08-31
• First posted: 2021-03-09
• Last updated: 2022-11-09

Locations

1 site across 1 country: Canada