WithDRawal Impact Of Postoperative Beta-Blocker

NCT05414331 | Terminated DMC

• 1 other identifier: 2000032771
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Bypass

Keywords

beta-blocker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adherence to medication and adjudication of endpoint

  3 months

• Adherence to medication and adjudication of endpoint

  6 months

• Adherence to medication and adjudication of endpoint

  12 months

• Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)

  baseline and 3 months

• Change in fatigue measured using the Fatigue Assessment Scale (FAS)

  baseline and 3 months

Study Arms (2)

Continuation of beta-blocker regimen

NO INTERVENTION

Participants will continue with current standard of care on current beta-blocker regimen

Withdrawing of beta-blockers

EXPERIMENTAL

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

Interventions

Discontinuing all beta-blocker OTHER

All beta-blockers will be stopped 2 months after CABG

Withdrawing of beta-blockers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• those who underwent combined valve + CABG surgery or aorta + CABG surgery.

Sponsors & Collaborators

• Yale University: lead
• Glenn Memorial Fund: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06511, United States

Location

Study Officials

• Arnar Geirsson, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Makoto Mori, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding will be only on the investigator interpreting CPET and adjudicating major cardiac and cerebrovascular events
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 1: The investigators will enroll patients with preserved EF (EF ≥50%) who underwent isolated elective or non-elective CABG at Yale New Haven Hospital (YNHH). Blocked randomization will be applied to ensure an equal sample size. Patients will be randomized to 1) continuation of the current BB regimen and 2) 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). Aim 2: Patients will be randomized at a 1-month postoperative visit, and the outcome will be adjudicated at 12 months since CABG. The safety endpoint is all-cause death, myocardial infarction, stroke, or repeat revascularization at 12 months. The investigators will measure patient-reported outcome on 1) 10-item activity level (VSAQ), 2) Fatigue Assessment Scale. 3) 15-item Vertigo Symptom Scale at the time of enrollment and 3 months.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 10, 2022
• Study Start: November 4, 2022
• Primary Completion: May 2, 2024
• Study Completion: May 30, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)