Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT)
European Heart Journal - Cardiovascular Pharmacotherapy
Abstract
There is a lack of evidence regarding the benefits of β-blocker treatment after invasively managed acute myocardial infarction (MI) without reduced left ventricular ejection fraction (LVEF).
The tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT) trial is a pragmatic, controlled, prospective, randomized, open-label blinded endpoint (PROBE design) clinical trial testing the benefits of β-blocker maintenance therapy in patients discharged after MI with or without ST-segment elevation. Patients eligible for participation are those managed invasively during index hospitalization (coronary angiography), with LVEF >40%, and no history of heart failure (HF). At discharge, patients will be randomized 1:1 to β-blocker therapy (agent and dose according to treating physician) or no β-blocker therapy. The primary endpoint is a composite of all-cause death, non-fatal reinfarction, or HF hospitalization over a median follow-up period of 2.75 years (minimum 2 years, maximum 3 years). Key secondary endpoints include the incidence of the individual components of the primary composite endpoint, the incidence of cardiac death, and incidence of malignant ventricular arrhythmias or resuscitated cardiac arrest. The primary endpoint will be analysed according to the intention-to-treat principle.
The REBOOT trial will provide robust evidence to guide the prescription of β-blockers to patients discharged after MI without reduced LVEF.
Contributors
Sergio Raposeiras-Roubin
Author
Roberto Latini
Author
Alberto Dominguez-Rodriguez
Author
José A Barrabés
Author
Pedro L Sánchez
Author
Manuel Anguita
Author
Felipe Fernández-Vázquez
Author
Domingo Pascual-Figal
Author
José M De la Torre Hernandez
Author
Stefano Ferraro
Author
Alfredo Vetrano
Author
José A Pérez-Rivera
Author
Oscar Prada-Delgado
Author
Noemí Escalera
Author
Lidia Staszewsky
Author
Jaume Agüero
Author
Stuart Pocock
Author
Filippo Ottani
Author
Valentín Fuster
Author
Borja Ibáñez
Author
National Centre for Cardiovascular Research CNIC AND Fundacion Jimenez Diaz Hospital Madrid , Spain
Abel Andres
Author
Adriano Autieri
Author
Albert Ariza
Author
Alberto Cordero
Author
Alessandra Costalunga
Author
Alessandro Navazio
Author
Alessandro Sionis
Author
Alfonso Torres
Author
Alfonso Valle
Author
Alfredo Bardaji
Author
Alfredo Renilla
Author
Alina Olaru
Author
Ana García-Alvarez
Author
Ana Maria Campos
Author
Angel Perez-Rivera
Author
Annalisa Aloisi
Author
Antonio Bayes-Genis
Author
Antonio Rizzo
Author
Barbara Coutsoumbas
Author
Beatrice Mariottoni
Author
Camilla Renèe Zawaideh
Author
Carlos Gonzalez-Juanatey
Author
Carlos Tomás Querol
Author
Carmen Rus
Author
Claudio Vimercati
Author
Danilo Saverio Vetrano
Author
Delicia Gentille
Author
Eduardo Alegría
Author
Eduardo Arroyo
Author
Eduardo Moreno Escobar
Author
Efrén Martínez-Quintana
Author
Elena Martinoli
Author
Elvira Marco
Author
Enrica Vitale
Author
Enrico Nicolis
Author
Erika Gazzola
Author
Ezio Mesolella
Author
Felipe Navarro
Author
Francesco Manca
Author
Francisco Fernández-Aviles
Author
Francisco Marin-Ortuño
Author
Francisco Torres
Author
Gabriel Vázquez-Oliva
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Gian Piero Perna
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Gianni Casella
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Giovanni Sirianni
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Giuletta Grigis
Author
Giulia Bugani
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Giulia Pongetti
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Giuseppe Di Tano
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Gonzalo Navarrete
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Hector Bueno
Author
Hugo Paris
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Ines Moeller
Author
Isidro Hernandez
Author
Ivana Pariggiano
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J Alberto San Román
Author
Javier Botas
Author
Jordi Palet
Author
Jorge Sanchez
Author
Jose A Ramirez
Author
José Angel Cabrera
Author
José Díaz
Author
José Manuel García Ruiz
Author
Jose R Gonzalez-Juanatey
Author
Jose Rozado
Author
Josep Maria Alegret
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Juan C García Rubira
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Juan Luis Bonilla
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Juan Ruiz-García
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Juan Sanchis
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Julio Hernandez
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Lorenzo Calò
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Mª Jesus Rollan
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Manuel de Mora
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Marco Solari
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Maria Giulia Perrelli
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Maria Rosa de Iacono
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Mariachiara Buffa
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Mario Lombardi
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Matteo Bianco
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Mauro Rondi
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Natale Brunetti
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Nicoletta De Cesare
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Nicoletta De Santis
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Oscar Diaz
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Oscar Fabregat-Andres
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Pablo Bazal
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Pedro Morillas
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Petra Sanz
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Pierangelo Basso
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Ricardo Ieva
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Roberto Carletti
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Roberto Martin
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Roman Freixa
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Rosa Fernandez
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Rosario Ortas
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Sabina Meloni
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Stefano Tondi
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Valentina Regazzoni
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Vicente Mora
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Agustín Martín García
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Alba Cervero
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Alba Martin
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Albert Duran Cambra
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Albert Massó-van Roessel
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Alberto Pérez
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Alberto Pullara
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Albina Aldomà
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Alejandro Amador
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Alejandro Junco
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Alejandro Pascual
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Alejandro Rodriguez
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Alejandro Villanueva
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Alice Vitagliano
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Alicia Bautista Pavés
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Alicia Gainza
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Alicia Moreno
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Alvaro Aceña
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Alvaro Vicedo
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Andrea Cafro
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Andrea Chiampan
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Andrea Finzi
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Andrea Kallmeyer
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Andrea Lopez
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Andrea Rubboli
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Andrea Veliz
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Andrés Iñiguez
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Andres Morist
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Ane Aboitiz
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Angel Franch
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Angela Alonso
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Angela Juez
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Angelica Romero
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Anna Carrasquer
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Antonella Vasamì
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Antoni Perelló-Bordoy
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Antonia Sambola
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Antonio Gamez
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Antonio Jesus Martín
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Antonio Lara-Padrón
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Antonio Miñano
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Antonio Piñero
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Antonio Quesada
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Antonio Tello
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Aritz Gil
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Armando Perez
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Aurora Diaz
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Beatriz Saiz
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Beatriz Samaniego
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Beatriz Sampedro
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Belen Alvarez
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Bernardo Ayala Borges
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Carla Jimenez
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Carlos Baladrón
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Carlos Galán
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Carlos Millan Rodriguez
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Carlos Ortiz
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Charo Cortina
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Chiara Angeletti
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Clea Gonzalez
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Emanuela Clara Bertolino
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Enrico Gotti
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Enrique Sanchez
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