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

Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Drug: Discontinuation of β-blocker

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 2540
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joo-Yong Hahn, MD,PhD; Phone Number: 82-2-3410-6653; Email: jyhahn@skku.edu
• Study Contact Backup: Name: Ki Hong Choi; Phone Number: 82-2-3410-3419; Email: cardiokh@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
    • Contact: Joo-Yong Hahn, MD, PhD; Phone Number: 82-2-3410-6653; Email: ichjy1@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: β-blocker discontinuation arm; Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction	Drug: Discontinuation of β-blocker; Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
No Intervention: β-blocker maintenance arm; Continuation of β-blocker therapy after acute myocardial infarction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events	a composite of all-cause death, myocardial infarction, hospitalization for heart failure	2.5 years after last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death		2.5 years after last patient enrollment
Myocardial infarction		2.5 years after last patient enrollment
Any hospitalization		2.5 years after last patient enrollment
Hospitalization for heart failure		2.5 years after last patient enrollment
Hospitalization for acute coronary syndrome		2.5 years after last patient enrollment
All-cause death or myocardial infarction		2.5 years after last patient enrollment
Myocardial infarction or hospitalization for heart failure		2.5 years after last patient enrollment
Any revascularization		2.5 years after last patient enrollment
Myocardial infarction or any revascularization		2.5 years after last patient enrollment
Atrial fibrillation occurrence		2.5 years after last patient enrollment
Adverse effects related with β-blocker		2.5 years after last patient enrollment
left ventricle ejection fraction	changes in left ventricle ejection fraction	at 2 years
N-terminal pro-brain natriuretic peptide (NT-proBNP)	changes in NT-proBNP	2.5 years after last patient enrollment
Medical cost	The medical expenses related to heart problems during the follow-up	at 2 years
PROMIS 29	PROMIS 29 is composed of a total of 29 questions, and questions are composed of domains for physical function, anxiety, depression, sleep, social function, participation availability, and pain.	2.5 years after last patient enrollment
Cardiovascular death		2.5 years after last patient enrollment
Cardiovascular death or myocardial infarction		2.5 years after last patient enrollment
Cardiovascular death, myocardial infarction, or hospitalization for heart failure		2.5 years after last patient enrollment
Cardiovascular death, myocardial infarction, or any revascularization		2.5 years after last patient enrollment
Rate of Stroke	Rate of ischemic or hemorrhagic stroke	2.5 years after last patient enrollment
Rate of Hospitalization for cardiovascular causes	Rate of Hospitalization for cardiovascular causes	2.5 years after last patient enrollment

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Chonbuk National University Hospital; Chonnam National University Hospital; Korea University Anam Hospital; Seoul National University Bundang Hospital; Gyeongsang National University Hospital; Kangbuk Samsung Hospital; Keimyung University Dongsan Medical Center; Jeju National University Hospital; Sejong General Hospital; Saint Vincent's Hospital, Korea; Chungnam National University Hospital; Wonju Severance Christian Hospital; Wonkwang University Hospital; Chungbuk National University Hospital; Chosun University Hospital; Kyung Hee University Hospital; Presbyterian medical center; Inje University Ilsan Paik Hospital; Ewha Womans University Seoul Hospital; Samsung Changwon Hospital
• Investigators: Principal Investigator: Joo-Yong Hahn, MD,PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine

Publications and helpful links

General Publications

• Choi KH, Kim J, Kang D, Doh JH, Kim J, Park YH, Ahn SG, Kim W, Park JP, Kim SM, Cho BR, Nam CW, Cho JH, Joo SJ, Suh J, Jeong JO, Jang W, Yoon CH, Hwang JY, Lim SH, Lee SR, Shin ES, Kim BJ, Yu CW, Her SH, Kim HK, Park KT, Kim J, Park TK, Lee JM, Cho J, Yang JH, Song YB, Choi SH, Gwon HC, Guallar E, Hahn JY; SMART-DECISION investigators. Discontinuation of beta-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial. BMJ Open. 2024 Aug 31;14(8):e086971. doi: 10.1136/bmjopen-2024-086971.

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 21, 2021
• First Submitted That Met QC Criteria: February 21, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agents; Adrenergic Antagonists; Adrenergic beta-Antagonists
• Other Study ID Numbers: SMC202010176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No