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

Yale University

Status: Terminated

Conditions: Coronary Artery Bypass

Treatments: Other: Discontinuing all beta-blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT05414331

2000032771

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Continuation of beta-blocker regimen

No Intervention group

Description:

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

Withdrawing of beta-blockers

Experimental group

Description:

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).

Treatment:

Other: Discontinuing all beta-blocker