NCT03596385

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8,505 (actual)
• Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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).

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Beta blocker	long-term maintenance beta-blocker therapy

Timeline

• Start date: 2018-10-31
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2018-07-23
• Last updated: 2025-06-06

Locations

111 sites across 2 countries: Italy, Spain