TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"
- Registration Number
- NCT03596385
- Lead Sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8505
- ≥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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Beta-blocker therapy Beta blocker 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
- Primary Outcome Measures
Name Time Method Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE) 12-54 months since the beginning (median follow up anticipated 3.75 years) 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%)
- Secondary Outcome Measures
Name Time Method 1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality. 12-54 months since the beginning (median follow up anticipated 3.75 years) absolute number of events (% from total patients recruited) of the components of the MACE (eg number of all cause deaths (% from patients included) in active arm vs control).
First event of each individual component counts for secondary outcome.
EXAMPLE all cause death events in in arm 1: 200 deaths (200 events/4234 patients enroled: event rate 4.72%).
nonfatal reinfarctions in in arm 1: 150 reinfarctions (150 events/4234 patients enroled: event rate 3.54%).
note that in the example of the primary outcome, only 150 deaths are counted and for the secondary outcome 200. This is because in this hypothetical case, 50 deaths occurred in patients who previously experienced a nonfatal reinfarction
Trial Locations
- Locations (103)
Ospedale Civile Santi Antonio e Biagio
🇮🇹Alessandria, Italy
Teresa Masselli Mascia
🇮🇹San Severo, Foggia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
🇮🇹Ancona, Italy
Ospedale Civile
🇮🇹Baggiovara, Italy
Santa Margherita
🇮🇹Cortona, Italy
Ospedale San Paolo
🇮🇹Bari, Italy
A.O. Sant'Anna e San Sebastiano di Caserta
🇮🇹Caserta, Italy
Ospedale di Cremona
🇮🇹Cremona, Italy
Ospedale Maggiore
🇮🇹Bologna, Italy
Ospedale di Vaio
🇮🇹Fidenza, Italy
Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia
🇮🇹Foggia, Italy
Ospedale di Desio
🇮🇹Desio, Italy
Ospedale Gualdo Tadino
🇮🇹Gubbio, Italy
Villa Sofía, Palermo
🇮🇹Palermo, Italy
Ospedale Civile di Legnano
🇮🇹Legnano, Italy
Ospedale San Luigi Gonzaga
🇮🇹Orbassano, Italy
Policlinico San Marco
🇮🇹Osio Sotto, Italy
Ospedale di Vizzolo Predabissi
🇮🇹Melegnano, Italy
Ospedale Sacro Cuore Don Calabria
🇮🇹Negrar, Italy
Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
P.O. di Passirana
🇮🇹Passirana, Italy
Ospedale Infermi di Rimini
🇮🇹Rimini, Italy
Ospedale G. da Saliceto ,Piacenza
🇮🇹Piacenza, Italy
Ospedalel Santa Maria delle Croci
🇮🇹Ravenna, Italy
Ospedale Veris Delli Ponti
🇮🇹Scorrano, Italy
Presidio Ospedaliero di Saronno
🇮🇹Saronno, Italy
Txagorritxu
🇪🇸Alava, Spain
Ospedale di Treviglio
🇮🇹Treviglio, Italy
Hospital Alto del Gualdalquivir
🇪🇸Andújar, Spain
Fundacion Alcorcon
🇪🇸Alcorcón, Spain
Virgen de los Lirios de Alcoy
🇪🇸Alcoy, Spain
San Agustin
🇪🇸Avilés, Spain
Centro Medico Teknon
🇪🇸Barcelona, Spain
Clinic
🇪🇸Barcelona, Spain
Consorci Sanitari Integral
🇪🇸Barcelona, Spain
H. Vall d´Hebron
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Universitario de Bellvitge
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hosptial Universitario Reina Sofia
🇪🇸Córdoba, Spain
H. Santa Lucía
🇪🇸Cartagena, Spain
Hospital Galdakao Usansolo
🇪🇸Galdakao, Spain
Hospital de Denia
🇪🇸Denia, Spain
Hospital universitario de Elche
🇪🇸Elche, Spain
Hospital Universitario de Vinalopo
🇪🇸Elche, Spain
Cabueñes
🇪🇸Gijón, Spain
Hospital San Cecilio
🇪🇸Granada, Spain
Hospital Universitario de Arnau de Vilanova
🇪🇸Lerida, Spain
Complejo Hospitalario Universitario de Jaen
🇪🇸Jaén, Spain
Complejo hospitalario universitario a Coruña
🇪🇸La Coruña, Spain
Hospital de Leon
🇪🇸León, Spain
Fundación Jiménez Díaz University Hospital
🇪🇸Madrid, Spain
Lucus Augusti
🇪🇸Lugo, Spain
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Clinica La Luz
🇪🇸Madrid, Spain
Hospital Quirón Pozuelo
🇪🇸Madrid, Spain
Hospital Clinico
🇪🇸Valencia, Spain
Ruber Juan Bravo
🇪🇸Madrid, Spain
Hospital Alvarez Buylla
🇪🇸Mieres, Spain
Hospital regional Universitario de Malaga
🇪🇸Málaga, Spain
Hospital de Manresa
🇪🇸Manresa, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Rey Juan Carlos
🇪🇸Móstoles, Spain
Hospital Universitario Central Asturias
🇪🇸Oviedo, Spain
Son Espases
🇪🇸Palma De Mallorca, Spain
Montecelo
🇪🇸Pontevedra, Spain
Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
H. Virgen del Rocio
🇪🇸Sevilla, Spain
Complejo hospitalario universitario de Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Universitario Sant Joan de Reus
🇪🇸Tarragona, Spain
Hospital Universitari Joan XXIII
🇪🇸Tarragona, Spain
Complejo hospitalario Universitario de Canarias
🇪🇸Tenerife, Spain
Hospital General de La Palma
🇪🇸Tenerife, Spain
Nuestra Señora de la Candelaria
🇪🇸Tenerife, Spain
Hospital Universitario de Torrejon
🇪🇸Torrejón De Ardoz, Spain
Hospital Universitario de Torrevieja
🇪🇸Torrevieja, Spain
Hospital universitario doctor Peset
🇪🇸Valencia, Spain
Hospital La Fe
🇪🇸Valencia, Spain
Hospital Infanta Elena
🇪🇸Valdemoro, Spain
Alvaro Cunqueiro
🇪🇸Vigo, Spain
Hospital Clinico universitario de Valladolid
🇪🇸Valladolid, Spain
Río Hortega
🇪🇸Valladolid, Spain
Hospital de Xativa
🇪🇸Xàtiva, Spain
Miguel Servet
🇪🇸Zaragoza, Spain
Hospital General de Villalba
🇪🇸Villalba, Spain
San Juan de la Cruz
🇪🇸Úbeda, Spain
H.Universitario de Elda
🇪🇸Elda, Spain
Hospital Arquitecto Macide
🇪🇸Ferrol, Spain
Hospital Virgen de las Nieves
🇪🇸Granada, Spain
H. Verge de la Cinta
🇪🇸Tortosa, Spain
Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
IMED Valencia
🇪🇸Valencia, Spain
Ospedale Misericordia
🇮🇹Grosseto, Italy
Ospedale C.G.Morgagni
🇮🇹Forlì, Italy
San Filippo Neri
🇮🇹Roma, Italy
Ospedale Bolognini
🇮🇹Seriate, Italy
Germans Trias i Pujol
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario Insular Materno Infantil
🇪🇸Las Palmas De Gran Canaria, Spain
Ruber Internacional
🇪🇸Madrid, Spain
Virgen de la Macarena
🇪🇸Sevilla, Spain