WithDRawal Impact Of Postoperative Beta-Blocker
- Conditions
- Coronary Artery Bypass
- Interventions
- Other: Discontinuing all beta-blocker
- Registration Number
- NCT05414331
- Lead Sponsor
- Yale University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
- 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.
- those who underwent combined valve + CABG surgery or aorta + CABG surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Withdrawing of beta-blockers Discontinuing all beta-blocker Discontinuation of all BB, and medication changes will be made at the 1-month clinic visit. A cardiopulmonary exercise test (CPET) will be performed 1 month after the randomization (2 months after CABG).
- Primary Outcome Measures
Name Time Method Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness 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 Outcome Measures
Name Time Method Adherence to medication and adjudication of endpoint 12 months Phone follow-ups at 12 months after CABG to ensure medication adherence and to adjudicate whether the endpoint had occurred
Change in fatigue measured using the Fatigue Assessment Scale (FAS) baseline and 3 months 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.
Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ) baseline and 3 months 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.
Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form baseline and 3 months 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 .
Trial Locations
- Locations (1)
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States