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

Last updated: June 3, 2025
Sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Overall Status: Completed

Phase

4

Condition

Circulation Disorders

Cardiac Disease

Congestive Heart Failure

Treatment

Beta blocker

Clinical Study ID

NCT03596385
REBOOT-CNIC
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old

  • Admitted for STEMI or NSTEMI and invasive management (i.e. coronary angiographyduring index hospitalization).

  • LVEF>40% as evaluated by any imaging technique anytime during hospitalization.

  • Signed informed consent

Exclusion

Exclusion Criteria:

  • Known allergy or intolerance to beta-blockers

  • Absolute contraindication to beta-blocker therapy according to treating physicianjudge

  • Prior history of HF, Killip class on admission or during hospitalization ≥ II

  • Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic ormitral valve area ≤1.0 cm2).

  • Any condition (appart from AMI) that requires beta-blocker prescription on dischargeaccording to treating physician judge

  • Any medical condition that, in the investigator´s judgment, would seriously limitlife expectancy (less than one year),

  • Patients participating in other clinical trials

Study Design

Total Participants: 8505
Treatment Group(s): 1
Primary Treatment: Beta blocker
Phase: 4
Study Start date:
October 31, 2018
Estimated Completion Date:
January 31, 2025

Study 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).

Connect with a study center

  • Teresa Masselli Mascia

    San Severo, Foggia
    Italy

    Site Not Available

  • Ospedale Civile Santi Antonio e Biagio

    Alessandria,
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Ancona,
    Italy

    Site Not Available

  • Ospedale Civile

    Baggiovara,
    Italy

    Site Not Available

  • Istituto Maugeri IRCCS

    Bari,
    Italy

    Site Not Available

  • Ospedale San Paolo

    Bari,
    Italy

    Site Not Available

  • Ospedale Maggiore

    Bologna,
    Italy

    Site Not Available

  • A.O. Sant'Anna e San Sebastiano di Caserta

    Caserta,
    Italy

    Site Not Available

  • Santa Margherita

    Cortona,
    Italy

    Site Not Available

  • Ospedale di Cremona

    Cremona,
    Italy

    Site Not Available

  • Ospedale di Desio

    Desio,
    Italy

    Site Not Available

  • Ospedale San Giuseppe

    Empoli,
    Italy

    Site Not Available

  • Ospedale di Vaio

    Fidenza,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia

    Foggia,
    Italy

    Site Not Available

  • Ospedale C.G.Morgagni

    Forlì,
    Italy

    Site Not Available

  • Ospedale Misericordia

    Grosseto,
    Italy

    Site Not Available

  • Ospedale Gualdo Tadino

    Gubbio,
    Italy

    Site Not Available

  • Ospedale Civile di Legnano

    Legnano,
    Italy

    Site Not Available

  • Ospedale di Vizzolo Predabissi

    Melegnano,
    Italy

    Site Not Available

  • Istituto di Ricerche Farmacologiche Mario Negri

    Milano,
    Italy

    Site Not Available

  • Mario Negri

    Milano,
    Italy

    Site Not Available

  • Ospedale San Paolo

    Milano,
    Italy

    Site Not Available

  • Ospedale Sacro Cuore Don Calabria

    Negrar,
    Italy

    Site Not Available

  • Ospedale San Luigi Gonzaga

    Orbassano,
    Italy

    Site Not Available

  • Policlinico San Marco

    Osio Sotto,
    Italy

    Site Not Available

  • Villa Sofía, Palermo

    Palermo,
    Italy

    Site Not Available

  • P.O. di Passirana

    Passirana,
    Italy

    Site Not Available

  • Ospedale G. da Saliceto ,Piacenza

    Piacenza,
    Italy

    Site Not Available

  • Ospedalel Santa Maria delle Croci

    Ravenna,
    Italy

    Site Not Available

  • Arcispedale S. Maria Nuova

    Reggio Emilia,
    Italy

    Site Not Available

  • Ospedale Infermi di Rimini

    Rimini,
    Italy

    Site Not Available

  • San Filippo Neri

    Roma,
    Italy

    Site Not Available

  • Presidio Ospedaliero di Saronno

    Saronno,
    Italy

    Site Not Available

  • Ospedale Veris Delli Ponti

    Scorrano,
    Italy

    Site Not Available

  • Ospedale Bolognini

    Seriate,
    Italy

    Site Not Available

  • Ospedale di Treviglio

    Treviglio,
    Italy

    Site Not Available

  • Ospedale di Udine

    Udine,
    Italy

    Site Not Available

  • Txagorritxu

    Alava,
    Spain

    Site Not Available

  • Fundacion Alcorcon

    Alcorcón,
    Spain

    Site Not Available

  • Virgen de los Lirios de Alcoy

    Alcoy,
    Spain

    Site Not Available

  • H. San Juan

    Alicante,
    Spain

    Site Not Available

  • Hospital Alto del Gualdalquivir

    Andújar,
    Spain

    Site Not Available

  • San Agustin

    Avilés,
    Spain

    Site Not Available

  • Centro Medico Teknon

    Barcelona,
    Spain

    Site Not Available

  • Clinic

    Barcelona,
    Spain

    Site Not Available

  • Consorci Sanitari Integral

    Barcelona,
    Spain

    Site Not Available

  • Germans Trias i Pujol

    Barcelona,
    Spain

    Site Not Available

  • H. Vall d´Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona,
    Spain

    Site Not Available

  • Hospital de Basurto

    Bilbao,
    Spain

    Site Not Available

  • Hospital Universitario de Burgos

    Burgos,
    Spain

    Site Not Available

  • H. Santa Lucía

    Cartagena,
    Spain

    Site Not Available

  • Hosptial Universitario Reina Sofia

    Córdoba,
    Spain

    Site Not Available

  • Hospital de Denia

    Denia,
    Spain

    Site Not Available

  • Hospital Universitario de Vinalopo

    Elche,
    Spain

    Site Not Available

  • Hospital universitario de Elche

    Elche,
    Spain

    Site Not Available

  • H.Universitario de Elda

    Elda,
    Spain

    Site Not Available

  • Hospital Arquitecto Macide

    Ferrol,
    Spain

    Site Not Available

  • Hospital Galdakao Usansolo

    Galdakao,
    Spain

    Site Not Available

  • Cabueñes

    Gijón,
    Spain

    Site Not Available

  • Hospital San Cecilio

    Granada,
    Spain

    Site Not Available

  • Hospital Virgen de las Nieves

    Granada,
    Spain

    Site Not Available

  • H.U Juan Ramón Jimenez

    Huelva,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario de Jaen

    Jaén,
    Spain

    Site Not Available

  • Complejo hospitalario universitario a Coruña

    La Coruña,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario Insular Materno Infantil

    Las Palmas De Gran Canaria,
    Spain

    Site Not Available

  • Hospital Universitario de Arnau de Vilanova

    Lerida,
    Spain

    Site Not Available

  • Hospital de Leon

    León,
    Spain

    Site Not Available

  • Lucus Augusti

    Lugo,
    Spain

    Site Not Available

  • CNIC

    Madrid,
    Spain

    Site Not Available

  • Clinica La Luz

    Madrid,
    Spain

    Site Not Available

  • Fundación Jiménez Díaz University Hospital

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital 12 de Octubre

    Madrid,
    Spain

    Site Not Available

  • Hospital Clinico

    Madrid,
    Spain

    Site Not Available

  • Hospital Gregorio Marañon

    Madrid,
    Spain

    Site Not Available

  • Hospital Quirón Pozuelo

    Madrid,
    Spain

    Site Not Available

  • Ruber Internacional

    Madrid,
    Spain

    Site Not Available

  • Ruber Juan Bravo

    Madrid,
    Spain

    Site Not Available

  • Hospital de Manresa

    Manresa,
    Spain

    Site Not Available

  • Hospital Alvarez Buylla

    Mieres,
    Spain

    Site Not Available

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Murcia,
    Spain

    Site Not Available

  • Hospital regional Universitario de Malaga

    Málaga,
    Spain

    Site Not Available

  • Rey Juan Carlos

    Móstoles,
    Spain

    Site Not Available

  • Hospital Universitario Central Asturias

    Oviedo,
    Spain

    Site Not Available

  • Son Espases

    Palma De Mallorca,
    Spain

    Site Not Available

  • Complejo Hospitalario de Navarra

    Pamplona,
    Spain

    Site Not Available

  • Montecelo

    Pontevedra,
    Spain

    Site Not Available

  • Clinico Universitario de Salamanca

    Salamanca,
    Spain

    Site Not Available

  • Marques de Valdecilla

    Santander,
    Spain

    Site Not Available

  • Complejo hospitalario universitario de Santiago

    Santiago De Compostela,
    Spain

    Site Not Available

  • H. Virgen del Rocio

    Sevilla,
    Spain

    Site Not Available

  • Virgen de la Macarena

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitari Joan XXIII

    Tarragona,
    Spain

    Site Not Available

  • Hospital Universitario Sant Joan de Reus

    Tarragona,
    Spain

    Site Not Available

  • Complejo hospitalario Universitario de Canarias

    Tenerife,
    Spain

    Site Not Available

  • Hospital General de La Palma

    Tenerife,
    Spain

    Site Not Available

  • Nuestra Señora de la Candelaria

    Tenerife,
    Spain

    Site Not Available

  • Hospital Universitario de Torrejon

    Torrejón De Ardoz,
    Spain

    Site Not Available

  • Hospital Universitario de Torrevieja

    Torrevieja,
    Spain

    Site Not Available

  • H. Verge de la Cinta

    Tortosa,
    Spain

    Site Not Available

  • Hospital Infanta Elena

    Valdemoro,
    Spain

    Site Not Available

  • Hospital Clinico

    Valencia,
    Spain

    Site Not Available

  • Hospital La Fe

    Valencia,
    Spain

    Site Not Available

  • Hospital universitario doctor Peset

    Valencia,
    Spain

    Site Not Available

  • IMED Valencia

    Valencia,
    Spain

    Site Not Available

  • Hospital Clinico universitario de Valladolid

    Valladolid,
    Spain

    Site Not Available

  • Río Hortega

    Valladolid,
    Spain

    Site Not Available

  • Alvaro Cunqueiro

    Vigo,
    Spain

    Site Not Available

  • Hospital General de Villalba

    Villalba,
    Spain

    Site Not Available

  • Hospital de Xativa

    Xàtiva,
    Spain

    Site Not Available

  • Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

  • San Juan de la Cruz

    Úbeda,
    Spain

    Site Not Available

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