Clinical trial NCT05414331: WithDRawal Impact Of Postoperative Beta-Blocker
Official title: WithDRawal Impact Of Postoperative Beta-Blocker
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Bypass
Keywords: beta-blocker
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Glenn Memorial Fund
First posted: 2022-06-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Peak oxygen consumption (VO2 max) to measure cardiorespiratory fitness
timeFrame: 1 month
Secondary outcomes:
measure: Adherence to medication and adjudication of endpoint
timeFrame: 3 months
measure: Adherence to medication and adjudication of endpoint
timeFrame: 6 months
measure: Adherence to medication and adjudication of endpoint
timeFrame: 12 months
measure: Change in activity level measured using the Veterans Specific Activity Questionnaire(VSAQ)
timeFrame: baseline and 3 months
measure: Change in fatigue measured using the Fatigue Assessment Scale (FAS)
timeFrame: baseline and 3 months
measure: Change in vertigo symptoms measured using the Vertigo Symptom Scale-short form
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Arnar Geirsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Makoto Mori, MD
role: PRINCIPAL_INVESTIGATOR
References: