TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"

Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Beta blocker

Study type: Interventional

Funder types: Other

Identifiers

NCT03596385

REBOOT-CNIC

Details and patient eligibility

About

REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after hospital discharge. All patients will be followed up for up to 5 years to determine the occurrence of adverse events (all cause mortality, re-infarction, and heart failure admission).

Full description

Pragmatic, controlled, prospective, randomized, open-label, blinded endpoint clinical trial testing the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI). Patients being discharged after an acute MI, with or without ST-segment elevation, and with a left ventricular ejection fraction >40%, and without history of heart failure (HF) prior to study inclusion, will be recruited. At discharge, patients will be randomized (1:1) to receive beta-blocker therapy (agent and dose according to treating physician) or no beta-blocker therapy. Primary outcome is the 5 years incidence of MACE (all cause mortality, reinfarction, heart failure admission).

Enrollment: 8,505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥18 years old
• Admitted for STEMI or NSTEMI and invasive management (i.e. coronary angiography during index hospitalization).
• LVEF>40% as evaluated by any imaging technique anytime during hospitalization.
• Signed informed consent

Exclusion criteria

• Known allergy or intolerance to beta-blockers
• Absolute contraindication to beta-blocker therapy according to treating physician judge
• Prior history of HF, Killip class on admission or during hospitalization ≥ II
• Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic or mitral valve area ≤1.0 cm2).
• Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
• Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
• Patients participating in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,505 participants in 2 patient groups

Beta-blocker therapy

Experimental group

Description:

This is a strategy (pragmatic) trial. In patients allocated to "Beta-blocker therapy", beta blocker agent and dose are decided by treating physician. betablocker therapy chosen might be any of the following: atenolol bisoprolol carvedilol metoprolol nebivolol

Treatment:

Drug: Beta blocker

Control (no beta-blocker therapy).

No Intervention group

Description:

Do not receive beta -blocker therapy