WithDRawal Impact Of Postoperative Beta-Blocker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-04

Study Completion Date

2024-05-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Coronary Artery Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Blinding will be only on the investigator interpreting CPET and adjudicating major cardiac and cerebrovascular events

Study Groups

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Continuation of beta-blocker regimen

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

Discontinuing all beta-blocker

Intervention Type OTHER

All beta-blockers will be stopped 2 months after CABG

Interventions

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Discontinuing all beta-blocker

All beta-blockers will be stopped 2 months after CABG

Intervention Type OTHER

Eligibility Criteria

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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.