WithDRawal Impact Of Postoperative Beta-Blocker
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Bypass
- Sponsor
- Yale University
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants who underwent coronary artery bypass graft(CABG) surgery at Yale New Haven Hospital who presented to 1-month postoperative visit
- •ejection fraction \>50%, and in sinus rhythm at the time of hospital discharge or enrollment.
Exclusion Criteria
- •those who underwent combined valve + CABG surgery or aorta + CABG surgery.
Outcomes
Primary Outcomes
Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
Time Frame: 1 month
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.
Secondary Outcomes
- Change in fatigue measured using the Fatigue Assessment Scale (FAS)(baseline and 3 months)
- Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)(baseline and 3 months)
- Adherence to medication and adjudication of endpoint(12 months)
- Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form(baseline and 3 months)