TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"
1 other identifier
interventional
8,505
2 countries
111
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2018
Longer than P75 for phase_4
111 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 23, 2018
CompletedStudy Start
First participant enrolled
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedJune 6, 2025
June 1, 2025
6.3 years
June 15, 2018
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
absolute number of patients experiencing deaths will be added to number of patients experiencing a non fatal reinfarction and to number of patients experiencing heart failure hospitalization. If a patient experience more than one of these events, only first event will be added for the sum of events EXAMPLE events in arm 1: 150 deaths+150 reinfarctions+150 heart failure hospitalizations= TOTAL 450 MACE (450 events/4234 patients enroled: event rate 10.63%)
12-54 months since the beginning (median follow up anticipated 3.75 years)
Secondary Outcomes (1)
2.1 Incidence rate of individual components of the primary outcome. 2.2 Incidence rate of cardiac mortality. 2.3 Incidence of sustained ventricular tachycardia/ventricular fibrillation (VT/VF) and resuscitated cardiac arrest.
12-54 months since the beginning (median follow up anticipated 3.75 years)
Other Outcomes (1)
3.1 Incidence of revascularizations during follow-up 3.2 Composite of cardiac death, stroke or myocardial infarction. 3.3 Safety endpoints 3.4 Quality of life and functional status (telephone evaluation):
12-54 months since the beginning (median follow up anticipated 3.75 years)
Study Arms (2)
Beta-blocker therapy
EXPERIMENTALThis 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
Control (no beta-blocker therapy).
NO INTERVENTIONDo not receive beta -blocker therapy
Interventions
long-term maintenance beta-blocker therapy
Eligibility Criteria
You may qualify if:
- ≥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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (111)
Teresa Masselli Mascia
San Severo, Foggia, Italy
Ospedale Civile Santi Antonio e Biagio
Alessandria, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, Italy
Ospedale Civile
Baggiovara, Italy
Istituto Maugeri IRCCS
Bari, Italy
Ospedale San Paolo
Bari, Italy
Ospedale Maggiore
Bologna, Italy
A.O. Sant'Anna e San Sebastiano di Caserta
Caserta, Italy
Santa Margherita
Cortona, Italy
Ospedale di Cremona
Cremona, Italy
Ospedale di Desio
Desio, Italy
Ospedale San Giuseppe
Empoli, Italy
Ospedale di Vaio
Fidenza, Italy
Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia
Foggia, Italy
Ospedale C.G.Morgagni
Forlì, Italy
Ospedale Misericordia
Grosseto, Italy
Ospedale Gualdo Tadino
Gubbio, Italy
Ospedale Civile di Legnano
Legnano, Italy
Ospedale di Vizzolo Predabissi
Melegnano, Italy
Mario Negri
Milan, Italy
Ospedale San Paolo
Milan, Italy
Ospedale Sacro Cuore Don Calabria
Negrar, Italy
Ospedale San Luigi Gonzaga
Orbassano, Italy
Policlinico San Marco
Osio Sotto, Italy
Villa Sofía, Palermo
Palermo, Italy
P.O. di Passirana
Passirana, Italy
Ospedale G. da Saliceto ,Piacenza
Piacenza, Italy
Ospedalel Santa Maria delle Croci
Ravenna, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale Infermi di Rimini
Rimini, Italy
San Filippo Neri
Roma, Italy
Presidio Ospedaliero di Saronno
Saronno, Italy
Ospedale Veris Delli Ponti
Scorrano, Italy
Ospedale Bolognini
Seriate, Italy
Ospedale di Treviglio
Treviglio, Italy
Ospedale di Udine
Udine, Italy
Fundación Jiménez Díaz University Hospital
Madrid, Madrid, 28040, Spain
Complejo hospitalario universitario a Coruña
A Coruña, Spain
Txagorritxu
Alava, Spain
Fundacion Alcorcon
Alcorcón, Spain
Virgen de los Lirios de Alcoy
Alcoy, Spain
H. San Juan
Alicante, Spain
Hospital Alto del Gualdalquivir
Andújar, Spain
San Agustin
Avilés, Spain
Centro Medico Teknon
Barcelona, Spain
Clinic
Barcelona, Spain
Consorci Sanitari Integral
Barcelona, Spain
Germans Trias i Pujol
Barcelona, Spain
H. Vall d´Hebron
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital de Basurto
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
H. Santa Lucía
Cartagena, Spain
Hosptial Universitario Reina Sofia
Córdoba, Spain
Hospital de Denia
Denia, Spain
Hospital universitario de Elche
Elche, Spain
Hospital Universitario de Vinalopo
Elche, Spain
H.Universitario de Elda
Elda, Spain
Hospital Arquitecto Macide
Ferrol, Spain
Hospital Galdakao Usansolo
Galdakao, Spain
Cabueñes
Gijón, Spain
Hospital San Cecilio
Granada, Spain
Hospital Virgen de las Nieves
Granada, Spain
H.U Juan Ramón Jimenez
Huelva, Spain
Complejo Hospitalario Universitario de Jaen
Jaén, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
Las Palmas de Gran Canaria, Spain
Hospital de Leon
León, Spain
Hospital Universitario de Arnau de Vilanova
Lleida, Spain
Lucus Augusti
Lugo, Spain
Clinica La Luz
Madrid, Spain
CNIC
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Clinico
Madrid, Spain
Hospital Gregorio Marañon
Madrid, Spain
Hospital Quirón Pozuelo
Madrid, Spain
Ruber Internacional
Madrid, Spain
Ruber Juan Bravo
Madrid, Spain
Hospital de Manresa
Manresa, Spain
Hospital regional Universitario de Malaga
Málaga, Spain
Hospital Alvarez Buylla
Mieres, Spain
Rey Juan Carlos
Móstoles, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Universitario Central Asturias
Oviedo, Spain
Son Espases
Palma de Mallorca, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
Montecelo
Pontevedra, Spain
Clinico Universitario de Salamanca
Salamanca, Spain
Complejo hospitalario Universitario de Canarias
Santa Cruz de Tenerife, Spain
Hospital General de La Palma
Santa Cruz de Tenerife, Spain
Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Spain
Marques de Valdecilla
Santander, Spain
Complejo hospitalario universitario de Santiago
Santiago de Compostela, Spain
H. Virgen del Rocio
Seville, Spain
Virgen de la Macarena
Seville, Spain
Hospital Universitari Joan XXIII
Tarragona, Spain
Hospital Universitario Sant Joan de Reus
Tarragona, Spain
Hospital Universitario de Torrejon
Torrejón de Ardoz, Spain
Hospital Universitario de Torrevieja
Torrevieja, Spain
H. Verge de la Cinta
Tortosa, Spain
San Juan de la Cruz
Úbeda, Spain
Hospital Infanta Elena
Valdemoro, Spain
Hospital Clinico
Valencia, Spain
Hospital La Fe
Valencia, Spain
Hospital universitario doctor Peset
Valencia, Spain
IMED Valencia
Valencia, Spain
Hospital Clinico universitario de Valladolid
Valladolid, Spain
Río Hortega
Valladolid, Spain
Alvaro Cunqueiro
Vigo, Spain
Hospital General de Villalba
Villalba, Spain
Miguel Servet
Zaragoza, Spain
Related Publications (3)
Rossello X, Raposeiras-Roubin S, Latini R, Dominguez-Rodriguez A, Barrabes JA, Sanchez PL, Anguita M, Fernandez-Vazquez F, Pascual-Figal D, De la Torre Hernandez JM, Ferraro S, Vetrano A, Perez-Rivera JA, Prada-Delgado O, Escalera N, Staszewsky L, Pizarro G, Aguero J, Pocock S, Ottani F, Fuster V, Ibanez B; REBOOT-CNIC investigators. Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT). Eur Heart J Cardiovasc Pharmacother. 2022 May 5;8(3):291-301. doi: 10.1093/ehjcvp/pvab060.
PMID: 34351426BACKGROUNDIbanez B, Latini R, Rossello X, Dominguez-Rodriguez A, Fernandez-Vazquez F, Pelizzoni V, Sanchez PL, Anguita M, Barrabes JA, Raposeiras-Roubin S, Pocock S, Escalera N, Staszewsky L, Perez-Garcia CN, Diez-Villanueva P, Perez-Rivera JA, Prada-Delgado O, Owen R, Pizarro G, Caldes O, Gomez-Talavera S, Tunon J, Bianco M, Zarauza J, Vetrano A, Campos A, Martinez-Huertas S, Bueno H, Puentes M, Grigis G, Bonilla-Palomas JL, Marco E, Gonzalez-Juanatey JR, Bangueses R, Gonzalez-Juanatey C, Garcia-Alvarez A, Ruiz-Garcia J, Carrasquer A, Garcia-Rubira JC, Pascual-Figal D, Tomas-Querol C, San Roman JA, Baratta P, Aguero J, Martin-Reyes R, Colivicchi F, Ortas-Nadal R, Bazal P, Cordero A, Fernandez-Ortiz A, Basso P, Gonzalez E, Poletti F, Bugani G, Debiasio M, Cosmi D, Navazio A, Bermejo J, Tortorella G, Marini M, Botas J, de la Torre-Hernandez JM, Ottani F, Fuster V; REBOOT-CNIC Investigators. Beta-Blockers after Myocardial Infarction without Reduced Ejection Fraction. N Engl J Med. 2025 Nov 13;393(19):1889-1900. doi: 10.1056/NEJMoa2504735. Epub 2025 Aug 30.
PMID: 40888702DERIVEDGranger CB, Pocock SJ, Gersh BJ. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol. 2023 Feb;20(2):71-72. doi: 10.1038/s41569-022-00819-1. No abstract available.
PMID: 36526898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Borja Ibañez, MD PhD FESC
CNIC
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2018
First Posted
July 23, 2018
Study Start
October 31, 2018
Primary Completion
January 31, 2025
Study Completion
January 31, 2025
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share