Long-term Beta-blocker Therapy After Acute Myocardial Infarction
- Conditions
- Myocardial Infarction
- Interventions
- Drug: Discontinuation of β-blocker
- Registration Number
- NCT04769362
- Lead Sponsor
- Samsung Medical Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2540
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description β-blocker discontinuation arm Discontinuation of β-blocker Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction
- Primary Outcome Measures
Name Time Method Major adverse cardiac events 2.5 years after last patient enrollment a composite of all-cause death, myocardial infarction, hospitalization for heart failure
- Secondary Outcome Measures
Name Time Method Adverse effects related with β-blocker 2.5 years after last patient enrollment All-cause death 2.5 years after last patient enrollment Cardiovascular 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 Cardiovascular 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 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 left ventricle ejection fraction at 2 years changes in left ventricle ejection fraction
N-terminal pro-brain natriuretic peptide (NT-proBNP) 2.5 years after last patient enrollment changes in NT-proBNP
Atrial fibrillation occurrence 2.5 years after last patient enrollment Medical cost at 2 years The medical expenses related to heart problems during the follow-up
PROMIS 29 2.5 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.
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of