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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03596385
• Other study ID #: REBOOT-CNIC
• Status: Recruiting
• Phase: Phase 4
• Start date: October 31, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
• Contact: Borja Ibañez, MD PhD FESC
• Phone: 914501200
• Email: bibanez[@]cnic.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 8468
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Beta blocker
long-term maintenance beta-blocker therapy

Locations

Country	Name	City	State
Italy	Ospedale Civile Santi Antonio e Biagio	Alessandria
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti	Ancona
Italy	Ospedale Civile	Baggiovara
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 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	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	Teresa Masselli Mascia	San Severo	Foggia
Italy	Presidio Ospedaliero di Saronno	Saronno
Italy	Ospedale Veris Delli Ponti	Scorrano
Italy	Ospedale Bolognini	Seriate
Italy	Ospedale di Treviglio	Treviglio
Spain	Txagorritxu	Alava
Spain	Fundacion Alcorcon	Alcorcón
Spain	Virgen de los Lirios de Alcoy	Alcoy
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	Complejo Hospitalario Universitario de Jaen	Jaén
Spain	Complejo hospitalario universitario a Coruña	La Coruña
Spain	Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria
Spain	Hospital de Leon	León
Spain	Hospital Universitario de Arnau de Vilanova	Lerida
Spain	Lucus Augusti	Lugo
Spain	Clinica La Luz	Madrid
Spain	Fundación Jiménez Díaz University Hospital	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 regional Universitario de Malaga	Málaga
Spain	Hospital de Manresa	Manresa
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	Marques de Valdecilla	Santander
Spain	Complejo hospitalario universitario de Santiago	Santiago De Compostela
Spain	H. Virgen del Rocio	Sevilla
Spain	Virgen de la Macarena	Sevilla
Spain	Hospital Universitari Joan XXIII	Tarragona
Spain	Hospital Universitario Sant Joan de Reus	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	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	Hospital de Xativa	Xàtiva
Spain	Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Countries where clinical trial is conducted

Italy,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	1) Incidence of subsequent revascularizations. 2) Incidence of ICD (including CRT) insertion.	absolute number of events (% from total patients recruited) in each treatment arm experiencing any of the components of the MACE.; First event of each individual component counts for secondary outcome.	12-54 months since the beginning (median follow up anticipated 3.75 years)
Primary	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	1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality.	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	12-54 months since the beginning (median follow up anticipated 3.75 years)