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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04769362
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 3, 2023
Sponsor:
Collaborators:
Kangbuk Samsung Hospital
Gyeongsang National University Hospital
Kyung Hee University Hospital
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Sejong General Hospital
Seoul National University Bundang Hospital
Samsung Changwon Hospital
Saint Vincent's Hospital, Korea
Presbyterian medical center
Wonkwang University Hospital
Wonju Severance Christian Hospital
Ewha Womans University Seoul Hospital
Inje University Ilsan Paik Hospital
Chonbuk National University Hospital
Chonnam National University Hospital
Jeju National University Hospital
Chosun University Hospital
Chungbuk National University Hospital
Chungnam National University Hospital
Information provided by (Responsible Party):
Joo-Yong Hahn, Samsung Medical Center

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Discontinuation of β-blocker Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial
Actual Study Start Date : May 4, 2021
Estimated Primary Completion Date : March 20, 2026
Estimated Study Completion Date : March 20, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 2 years after last patient enrollment ]
    a composite of all-cause death, myocardial infarction, hospitalization for heart failure


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 2 years after last patient enrollment ]
  2. Cardiac death [ Time Frame: 2 years after last patient enrollment ]
  3. Myocardial infarction [ Time Frame: 2 years after last patient enrollment ]
  4. Any hospitalization [ Time Frame: 2 years after last patient enrollment ]
  5. Hospitalization for heart failure [ Time Frame: 2 years after last patient enrollment ]
  6. Hospitalization for acute coronary syndrome [ Time Frame: 2 years after last patient enrollment ]
  7. All-cause death or myocardial infarction [ Time Frame: 2 years after last patient enrollment ]
  8. Cardiac death or myocardial infarction [ Time Frame: 2 years after last patient enrollment ]
  9. Myocardial infarction or hospitalization for heart failure [ Time Frame: 2 years after last patient enrollment ]
  10. Any revascularization [ Time Frame: at 2 years after randomization ]
  11. Myocardial infarction or any revascularization [ Time Frame: 2 years after last patient enrollment ]
  12. Cardiac death, myocardial infarction, or any revascularization [ Time Frame: 2 years after last patient enrollment ]
  13. Left ventricle ejection fraction [ Time Frame: 2 years after last patient enrollment ]
  14. N-terminal pro-brain natriuretic peptide (NT-proBNP) [ Time Frame: at 2 years ]
  15. Atrial fibrillation occurrence [ Time Frame: 2 years after last patient enrollment ]
  16. Medical cost [ Time Frame: 2 years after last patient enrollment ]
    The medical expenses related to heart problems during the follow-up

  17. PROMIS 29 [ Time Frame: 2 years after last patient enrollment ]
    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.

  18. Adverse effects related with β-blocker [ Time Frame: 2 years after last patient enrollment ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04769362


Contacts
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Contact: Joo-Yong Hahn, MD,PhD 82-2-3410-6653 jyhahn@skku.edu
Contact: Ki Hong Choi 82-2-3410-3419 cardiokh@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Joo-Yong Hahn, MD, PhD    82-2-3410-6653    ichjy1@gmail.com   
Sponsors and Collaborators
Samsung Medical Center
Kangbuk Samsung Hospital
Gyeongsang National University Hospital
Kyung Hee University Hospital
Keimyung University Dongsan Medical Center
Korea University Anam Hospital
Sejong General Hospital
Seoul National University Bundang Hospital
Samsung Changwon Hospital
Saint Vincent's Hospital, Korea
Presbyterian medical center
Wonkwang University Hospital
Wonju Severance Christian Hospital
Ewha Womans University Seoul Hospital
Inje University Ilsan Paik Hospital
Chonbuk National University Hospital
Chonnam National University Hospital
Jeju National University Hospital
Chosun University Hospital
Chungbuk National University Hospital
Chungnam National University Hospital
Investigators
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Principal Investigator: Joo-Yong Hahn, MD,PhD Samsung Medical Center, Sungkyunkwan University School of Medicine
More Information
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Responsible Party: Joo-Yong Hahn, MD, PhD, Division of Cardiology, Department of Medicine, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04769362    
Other Study ID Numbers: SMC202010176
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs