Samsung Medical Center
Seoul, 06351, South Korea
Location status: Recruiting
NCT Number: NCT04769362
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 4
Seoul, 06351, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
Time frame: 2.5 years after last patient enrollment
a composite of all-cause death, myocardial infarction, hospitalization for heart failure
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Time frame: at 2 years
changes in left ventricle ejection fraction
Time frame: 2.5 years after last patient enrollment
changes in NT-proBNP
Time frame: 2.5 years after last patient enrollment
Time frame: at 2 years
The medical expenses related to heart problems during the follow-up
Time frame: 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.
Time frame: 2.5 years after last patient enrollment
Time frame: 2.5 years after last patient enrollment
Rate of Hospitalization for cardiovascular causes
Time frame: 2.5 years after last patient enrollment
Rate of ischemic or hemorrhagic stroke
Contact information is provided by the study sponsor or research team.
Joo-Yong Hahn, MD,PhD
CONTACT
Ki Hong Choi
CONTACT
Samsung Medical Center
Other
Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial
Acronym: SMART-DECISION
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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