The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.
Aim 1: The primary aim is to evaluate the impact of withdrawing BB on exercise capacity (peak oxygen consumption, VO2 max) in patients who underwent CABG. The investigators hypothesize that withdrawing BB 1 month after CABG will improve exercise capacity 2 months after CABG. Aim 2: The secondary objectives are to evaluate the impact of withdrawing BB on a MACCE (major adverse cardiac and cerebrovascular event) and fatigue-related symptoms in patients who underwent CABG. The investigators hypothesize that withdrawing BB after CABG for 1 year will be non-inferior to continuing BB in terms of MACCE incidence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
43
All beta-blockers will be stopped 2 months after CABG
Yale New Haven Hospital
New Haven, Connecticut, United States
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
Peak oxygen measured in ml/kg/min consumption will be measured on CPET 1 month after randomization and be compared controls. This is an important measure of exercise capacity, which has been shown to decrease in other population when on beta-blocker. The higher the measure, the better with measures greater than 12.3 ml/kg/min as positive.
Time frame: 1 month
Adherence to medication and adjudication of endpoint
Phone follow-ups at 3 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Time frame: 3 months
Adherence to medication and adjudication of endpoint
Phone follow-ups at 6 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Time frame: 6 months
Adherence to medication and adjudication of endpoint
Phone follow-ups at 12 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Time frame: 12 months
Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)
VSAQ, a 10-item self reported questionnaire will be used to assess activity levels. Participants choose which item best describes their condition best. Items range from 1(low activity) to 13(higher activity). The higher the score, the more active.
Time frame: baseline and 3 months
Change in fatigue measured using the Fatigue Assessment Scale (FAS)
The FAS is a self reported 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. The total score ranges from 10 to 50. A total FAS score \< 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
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Time frame: baseline and 3 months
Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form
The 15-item short form self report Vertigo Symptom Scale will be used to assess symptoms: 8 items relating to vertigo-balance, and 7 items relating to autonomic-anxiety symptoms. Each item is scored on a 5-point scale (range 0-4) and the total scale score ranges 0-60 with higher scores indicating more severe problems. Severe dizziness indicated by a score of ≥ 12 points .
Time frame: baseline and 3 months