WithDRawal Impact Of Postoperative Beta-Blocker

Coronary Artery Bypass Clinical Trial

— DROP-BB  

Official title:

WithDRawal Impact Of Postoperative Beta-Blocker

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05414331
• Other study ID #: 2000032771
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: Makoto Mori, MD PhD
• Phone: 475-201-8349
• Email: makoto.mori[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators will evaluate the impact of withdrawing beta-blocker medication after coronary artery bypass surgery with this randomized controlled trial.

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 information / eligibility

• Status: Recruiting
• Enrollment: 406
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Other:
• Discontinuing all beta-blocker
All beta-blockers will be stopped 2 months after CABG

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Glenn Memorial Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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	3 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	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.	baseline and 3 months
Secondary	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.	baseline and 3 months
Secondary	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 .	baseline and 3 months