Clinical trial NCT03596385: TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"
Official title: TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Lead sponsor: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 8505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Eligibility criteria: Inclusion Criteria:

* ≥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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
timeFrame: 12-54 months since the beginning (median follow up anticipated 3.75 years)
Secondary outcomes:
measure: 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.
timeFrame: 12-54 months since the beginning (median follow up anticipated 3.75 years)
Other outcomes:
measure: 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):
timeFrame: 12-54 months since the beginning (median follow up anticipated 3.75 years)
Locations:
city: San Severo
country: Italy
facility: Teresa Masselli Mascia
state: Foggia
city: Alessandria
country: Italy
facility: Ospedale Civile Santi Antonio e Biagio
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti
city: Baggiovara
country: Italy
facility: Ospedale Civile
city: Bari
country: Italy
facility: Istituto Maugeri IRCCS
city: Bari
country: Italy
facility: Ospedale San Paolo
city: Bologna
country: Italy
facility: Ospedale Maggiore
city: Caserta
country: Italy
facility: A.O. Sant'Anna e San Sebastiano di Caserta
city: Cortona
country: Italy
facility: Santa Margherita
city: Cremona
country: Italy
facility: Ospedale di Cremona
city: Desio
country: Italy
facility: Ospedale di Desio
city: Empoli
country: Italy
facility: Ospedale San Giuseppe
city: Fidenza
country: Italy
facility: Ospedale di Vaio
city: Foggia
country: Italy
facility: Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia
city: Forlì
country: Italy
facility: Ospedale C.G.Morgagni
city: Grosseto
country: Italy
facility: Ospedale Misericordia
city: Gubbio
country: Italy
facility: Ospedale Gualdo Tadino
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano
city: Melegnano
country: Italy
facility: Ospedale di Vizzolo Predabissi
city: Milano
country: Italy
facility: Mario Negri
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
city: Orbassano
country: Italy
facility: Ospedale San Luigi Gonzaga
city: Osio Sotto
country: Italy
facility: Policlinico San Marco
city: Palermo
country: Italy
facility: Villa Sofía, Palermo
city: Passirana
country: Italy
facility: P.O. di Passirana
city: Piacenza
country: Italy
facility: Ospedale G. da Saliceto ,Piacenza
city: Ravenna
country: Italy
facility: Ospedalel Santa Maria delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
city: Roma
country: Italy
facility: San Filippo Neri
city: Saronno
country: Italy
facility: Presidio Ospedaliero di Saronno
city: Scorrano
country: Italy
facility: Ospedale Veris Delli Ponti
city: Seriate
country: Italy
facility: Ospedale Bolognini
city: Treviglio
country: Italy
facility: Ospedale di Treviglio
city: Udine
country: Italy
facility: Ospedale di Udine
city: Alava
country: Spain
facility: Txagorritxu
city: Alcorcón
country: Spain
facility: Fundacion Alcorcon
city: Alcoy
country: Spain
facility: Virgen de los Lirios de Alcoy
city: Alicante
country: Spain
facility: H. San Juan
city: Andújar
country: Spain
facility: Hospital Alto del Gualdalquivir
city: Avilés
country: Spain
facility: San Agustin
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Barcelona
country: Spain
facility: Clinic
city: Barcelona
country: Spain
facility: Consorci Sanitari Integral
city: Barcelona
country: Spain
facility: Germans Trias i Pujol
city: Barcelona
country: Spain
facility: H. Vall d´Hebron
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cartagena
country: Spain
facility: H. Santa Lucía
city: Córdoba
country: Spain
facility: Hosptial Universitario Reina Sofia
city: Denia
country: Spain
facility: Hospital de Denia
city: Elche
country: Spain
facility: Hospital universitario de Elche
city: Elche
country: Spain
facility: Hospital Universitario de Vinalopo
city: Elda
country: Spain
facility: H.Universitario de Elda
city: Ferrol
country: Spain
facility: Hospital Arquitecto Macide
city: Galdakao
country: Spain
facility: Hospital Galdakao Usansolo
city: Gijón
country: Spain
facility: Cabueñes
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Huelva
country: Spain
facility: H.U Juan Ramón Jimenez
city: Jaén
country: Spain
facility: Complejo Hospitalario Universitario de Jaen
city: La Coruña
country: Spain
facility: Complejo hospitalario universitario a Coruña
city: Las Palmas De Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno Infantil
city: Lerida
country: Spain
facility: Hospital Universitario de Arnau de Vilanova
city: León
country: Spain
facility: Hospital de Leon
city: Lugo
country: Spain
facility: Lucus Augusti
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz University Hospital
city: Madrid
country: Spain
facility: Clinica La Luz
city: Madrid
country: Spain
facility: CNIC
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Clinico
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Quirón Pozuelo
city: Madrid
country: Spain
facility: Ruber Internacional
city: Madrid
country: Spain
facility: Ruber Juan Bravo
city: Manresa
country: Spain
facility: Hospital de Manresa
city: Mieres
country: Spain
facility: Hospital Alvarez Buylla
city: Murcia
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital regional Universitario de Malaga
city: Móstoles
country: Spain
facility: Rey Juan Carlos
city: Oviedo
country: Spain
facility: Hospital Universitario Central Asturias
city: Palma De Mallorca
country: Spain
facility: Son Espases
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarra
city: Pontevedra
country: Spain
facility: Montecelo
city: Salamanca
country: Spain
facility: Clinico Universitario de Salamanca
city: Santander
country: Spain
facility: Marques de Valdecilla
city: Santiago De Compostela
country: Spain
facility: Complejo hospitalario universitario de Santiago
city: Sevilla
country: Spain
facility: H. Virgen del Rocio
city: Sevilla
country: Spain
facility: Virgen de la Macarena
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII
city: Tarragona
country: Spain
facility: Hospital Universitario Sant Joan de Reus
city: Tenerife
country: Spain
facility: Complejo hospitalario Universitario de Canarias
city: Tenerife
country: Spain
facility: Hospital General de La Palma
city: Tenerife
country: Spain
facility: Nuestra Señora de la Candelaria
city: Torrejón De Ardoz
country: Spain
facility: Hospital Universitario de Torrejon
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
city: Tortosa
country: Spain
facility: H. Verge de la Cinta
city: Valdemoro
country: Spain
facility: Hospital Infanta Elena
city: Valencia
country: Spain
facility: Hospital Clinico
city: Valencia
country: Spain
facility: Hospital La Fe
city: Valencia
country: Spain
facility: Hospital universitario doctor Peset
city: Valencia
country: Spain
facility: IMED Valencia
city: Valladolid
country: Spain
facility: Hospital Clinico universitario de Valladolid
city: Valladolid
country: Spain
facility: Río Hortega
city: Vigo
country: Spain
facility: Alvaro Cunqueiro
city: Villalba
country: Spain
facility: Hospital General de Villalba
city: Zaragoza
country: Spain
facility: Miguel Servet
city: Úbeda
country: Spain
facility: San Juan de la Cruz
Study officials:
affiliation: CNIC
name: Borja Ibañez, MD PhD FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.