WithDRawal Impact Of Postoperative Beta-Blocker (DROP-BB)

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Bypass
• Intervention / Treatment: Other: Discontinuing all beta-blocker

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Continuation of beta-blocker regimen; Participants will continue with current standard of care on current beta-blocker regimen
Experimental: Withdrawing of beta-blockers; 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).	Other: Discontinuing all beta-blocker; All beta-blockers will be stopped 2 months after CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Glenn Memorial Fund
• Investigators: Principal Investigator: Arnar Geirsson, MD, Yale University; Principal Investigator: Makoto Mori, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): May 2, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: beta-blocker
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agents; Adrenergic Antagonists; Adrenergic beta-Antagonists
• Other Study ID Numbers: 2000032771

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No