TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"
NCT ID: NCT03596385
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
8505 participants
INTERVENTIONAL
2018-10-31
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Beta-blocker therapy
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
Beta blocker
long-term maintenance beta-blocker therapy
Control (no beta-blocker therapy).
Do not receive beta -blocker therapy
No interventions assigned to this group
Interventions
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Beta blocker
long-term maintenance beta-blocker therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
OTHER
Responsible Party
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Principal Investigators
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Borja Ibañez, MD PhD FESC
Role: PRINCIPAL_INVESTIGATOR
CNIC
Locations
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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, 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
Countries
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References
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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.
Ibanez 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 Aug 30. doi: 10.1056/NEJMoa2504735. Online ahead of print.
Granger 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.
Other Identifiers
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REBOOT-CNIC
Identifier Type: -
Identifier Source: org_study_id
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