Long-term Beta-blocker Therapy After Acute Myocardial Infarction (SMART-DECISION)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2026
  • participants needed
    2540
  • sponsor
    Samsung Medical Center
Updated on 25 May 2022
heart failure
myocardial infarction
infarct
beta blockers
acute myocardial infarction

Summary

The aim of the study is to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without heart failure (HF) or left ventricular systolic dysfunction after acute myocardial infarction (AMI).

Prospective, open-label, randomized, multicenter, noninferiority trial to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.

Description

β-blockers have anti-ischemic, anti-arrhythmic, and anti-adrenergic properties. In order to reduce cardiovascular mortality and morbidity, current major guidelines recommend that oral treatment of β-blockers should be continued during and after hospitalization in patients with acute myocardial infarction (AMI) and without contraindications to β-blocker use.

A clinically important but difficult decision on β-blocker therapy after AMI is to determine the duration of β-blocker therapy after discharge in patients without heart failure (HF) or left ventricular systolic dysfunction. Previous studies for long-term β-blocker therapy after AMI were inadequate to derive definite conclusion because of small sample size and potential selection bias.

Therefore, the SMART-DECISION trial will investigate whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.

Details
Condition Myocardial Infarction
Treatment Discontinuation of β-blocker
Clinical Study IdentifierNCT04769362
SponsorSamsung Medical Center
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must be at least 19 years of age
Subject who have been continuing β-blocker therapy for at least 1 year after acute myocardial infarction regardless of the time of diagnosis
Subject is able to verbally confirm understandings of risks and benefits of this trial, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

Exclusion Criteria

Subject whose left ventricle ejection fraction was less than 40% from echocardiography performed after acute myocardial infarction or who have never received echocardiography
Treatment history of heart failure
Contraindication to β-blocker therapy (history of symptomatic bronchial asthma or chronic obstructive pulmonary disease, 2nd or 3rd degree AV block, cardiac pacemaker implantation, or other cases where β-blocker cannot be used under the judgment of the clinician)
Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
History of atrial fibrillation
Pregnancy or breast feeding
Severe renal dysfunction (creatinine clearance < 30 ml/min/1.73 m2)
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