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

Primary Purpose

Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Beta blocker
Sponsored by
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Teresa Masselli MasciaRecruiting
  • Ospedale Civile Santi Antonio e BiagioRecruiting
  • Azienda Ospedaliero Universitaria Ospedali RiunitiRecruiting
  • Ospedale CivileRecruiting
  • Ospedale San PaoloRecruiting
  • Ospedale MaggioreRecruiting
  • A.O. Sant'Anna e San Sebastiano di CasertaRecruiting
  • Santa MargheritaRecruiting
  • Ospedale di CremonaRecruiting
  • Ospedale di DesioRecruiting
  • Ospedale di VaioRecruiting
  • Azienda Ospedaliera Universitaria - Ospedali Riuniti FoggiaRecruiting
  • Ospedale C.G.MorgagniRecruiting
  • Ospedale MisericordiaRecruiting
  • Ospedale Gualdo TadinoRecruiting
  • Ospedale Civile di LegnanoRecruiting
  • Ospedale di Vizzolo PredabissiRecruiting
  • Ospedale Sacro Cuore Don CalabriaRecruiting
  • Ospedale San Luigi GonzagaRecruiting
  • Policlinico San MarcoRecruiting
  • Villa Sofía, PalermoRecruiting
  • P.O. di PassiranaRecruiting
  • Ospedale G. da Saliceto ,PiacenzaRecruiting
  • Ospedalel Santa Maria delle CrociRecruiting
  • Arcispedale S. Maria NuovaRecruiting
  • Ospedale Infermi di RiminiRecruiting
  • San Filippo NeriRecruiting
  • Presidio Ospedaliero di SaronnoRecruiting
  • Ospedale Veris Delli PontiRecruiting
  • Ospedale BologniniRecruiting
  • Ospedale di TreviglioRecruiting
  • TxagorritxuRecruiting
  • Fundacion AlcorconRecruiting
  • Virgen de los Lirios de AlcoyRecruiting
  • Hospital Alto del GualdalquivirRecruiting
  • San AgustinRecruiting
  • Centro Medico TeknonRecruiting
  • ClinicRecruiting
  • Consorci Sanitari IntegralRecruiting
  • Germans Trias i PujolRecruiting
  • H. Vall d´HebronRecruiting
  • Hospital de la Santa Creu i Sant PauRecruiting
  • Hospital Universitario de BellvitgeRecruiting
  • Hospital de BasurtoRecruiting
  • Hospital Universitario de BurgosRecruiting
  • H. Santa LucíaRecruiting
  • Hosptial Universitario Reina SofiaRecruiting
  • Hospital de DeniaRecruiting
  • Hospital universitario de ElcheRecruiting
  • Hospital Universitario de VinalopoRecruiting
  • H.Universitario de EldaRecruiting
  • Hospital Arquitecto MacideRecruiting
  • Hospital Galdakao UsansoloRecruiting
  • CabueñesRecruiting
  • Hospital San CecilioRecruiting
  • Hospital Virgen de las NievesRecruiting
  • Complejo Hospitalario Universitario de JaenRecruiting
  • Complejo hospitalario universitario a CoruñaRecruiting
  • Complejo Hospitalario Universitario Insular Materno InfantilRecruiting
  • Hospital Universitario de Arnau de VilanovaRecruiting
  • Hospital de LeonRecruiting
  • Lucus AugustiRecruiting
  • Fundación Jiménez Díaz University HospitalRecruiting
  • Clinica La LuzRecruiting
  • Hospital 12 de OctubreRecruiting
  • Hospital ClinicoRecruiting
  • Hospital Gregorio MarañonRecruiting
  • Hospital Quirón PozueloRecruiting
  • Ruber InternacionalRecruiting
  • Ruber Juan BravoRecruiting
  • Hospital de ManresaRecruiting
  • Hospital Alvarez BuyllaRecruiting
  • Hospital Clinico Universitario Virgen de la ArrixacaRecruiting
  • Hospital regional Universitario de MalagaRecruiting
  • Rey Juan CarlosRecruiting
  • Hospital Universitario Central AsturiasRecruiting
  • Son EspasesRecruiting
  • Complejo Hospitalario de NavarraRecruiting
  • MonteceloRecruiting
  • Clinico Universitario de SalamancaRecruiting
  • Marques de ValdecillaRecruiting
  • Complejo hospitalario universitario de SantiagoRecruiting
  • H. Virgen del RocioRecruiting
  • Virgen de la MacarenaRecruiting
  • Hospital Universitari Joan XXIIIRecruiting
  • Hospital Universitario Sant Joan de ReusRecruiting
  • Complejo hospitalario Universitario de CanariasRecruiting
  • Hospital General de La PalmaRecruiting
  • Nuestra Señora de la CandelariaRecruiting
  • Hospital Universitario de TorrejonRecruiting
  • Hospital Universitario de TorreviejaRecruiting
  • H. Verge de la CintaRecruiting
  • Hospital Infanta ElenaRecruiting
  • Hospital ClinicoRecruiting
  • Hospital La FeRecruiting
  • Hospital universitario doctor PesetRecruiting
  • IMED ValenciaRecruiting
  • Hospital Clinico universitario de ValladolidRecruiting
  • Río HortegaRecruiting
  • Alvaro CunqueiroRecruiting
  • Hospital General de VillalbaRecruiting
  • Hospital de XativaRecruiting
  • Miguel ServetRecruiting
  • San Juan de la CruzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Beta-blocker therapy

Control (no beta-blocker therapy).

Arm Description

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

Do not receive beta -blocker therapy

Outcomes

Primary Outcome Measures

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%)

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2018
Last Updated
October 16, 2023
Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT03596385
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2018 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
May 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 3 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 3 years incidence of MACE (all cause mortality, reinfarction, heart failure admission).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Beta-blocker therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Control (no beta-blocker therapy).
Arm Type
No Intervention
Arm Description
Do not receive beta -blocker therapy
Intervention Type
Drug
Intervention Name(s)
Beta blocker
Other Intervention Name(s)
atenolol, bisoprolol, carvedilol, metoprolol, nevibolol.
Intervention Description
long-term maintenance beta-blocker therapy
Primary Outcome Measure Information:
Title
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
Description
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%)
Time Frame
24-36 months since the beginning (median follow up anticipated 2.75 months)
Secondary Outcome Measure Information:
Title
1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality.
Description
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
Time Frame
24-36 months since the beginning (median follow up anticipated 2.75 months)
Other Pre-specified Outcome Measures:
Title
1) Incidence of subsequent revascularizations. 2) Incidence of ICD (including CRT) insertion.
Description
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.
Time Frame
24-36 months since the beginning (median follow up anticipated 2.75 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Borja Ibañez, MD PhD FESC
Phone
914501200
Ext
4302
Email
bibanez@cnic.es
First Name & Middle Initial & Last Name or Official Title & Degree
Noemi Escalera
Phone
914501200
Ext
5401
Email
nescalera@cnic.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Borja Ibañez, MD PhD FESC
Organizational Affiliation
CNIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Teresa Masselli Mascia
City
San Severo
State/Province
Foggia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Miscio
Facility Name
Ospedale Civile Santi Antonio e Biagio
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianfranco Pistis
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianpiero Perna
Facility Name
Ospedale Civile
City
Baggiovara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Tondi
Facility Name
Ospedale San Paolo
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Locuratolo
Facility Name
Ospedale Maggiore
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianni Casella
Facility Name
A.O. Sant'Anna e San Sebastiano di Caserta
City
Caserta
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Vetrano
Facility Name
Santa Margherita
City
Cortona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Cosmi
Facility Name
Ospedale di Cremona
City
Cremona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GB Danzi
Facility Name
Ospedale di Desio
City
Desio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Mollichelli
Facility Name
Ospedale di Vaio
City
Fidenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Tortorella
Facility Name
Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia
City
Foggia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natale Brunetti
Facility Name
Ospedale C.G.Morgagni
City
Forlì
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Ottani, MD PhD
Email
ottanif@alice.it
First Name & Middle Initial & Last Name & Degree
Filippo Ottani, MD PhD
Facility Name
Ospedale Misericordia
City
Grosseto
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Solari
Facility Name
Ospedale Gualdo Tadino
City
Gubbio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Cosmi
Facility Name
Ospedale Civile di Legnano
City
Legnano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Poletti
Facility Name
Ospedale di Vizzolo Predabissi
City
Melegnano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filippo Ottani
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Chiampan
First Name & Middle Initial & Last Name & Degree
Andrea Chiampan
Facility Name
Ospedale San Luigi Gonzaga
City
Orbassano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Montagna
Facility Name
Policlinico San Marco
City
Osio Sotto
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicoletta De Cesare
Facility Name
Villa Sofía, Palermo
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Lombardi
Facility Name
P.O. di Passirana
City
Passirana
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Martinoli
Facility Name
Ospedale G. da Saliceto ,Piacenza
City
Piacenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni Quinto
Facility Name
Ospedalel Santa Maria delle Croci
City
Ravenna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Rubboli
Facility Name
Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Navazio
Facility Name
Ospedale Infermi di Rimini
City
Rimini
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Valentini
Facility Name
San Filippo Neri
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefania Di Fusco
Facility Name
Presidio Ospedaliero di Saronno
City
Saronno
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Nassiacos
Facility Name
Ospedale Veris Delli Ponti
City
Scorrano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugenio Vilei
Facility Name
Ospedale Bolognini
City
Seriate
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Costalunga
Facility Name
Ospedale di Treviglio
City
Treviglio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Sganzerla
Facility Name
Txagorritxu
City
Alava
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Torres
Facility Name
Fundacion Alcorcon
City
Alcorcón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Botas
Facility Name
Virgen de los Lirios de Alcoy
City
Alcoy
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillermo Grau
Facility Name
Hospital Alto del Gualdalquivir
City
Andújar
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Rus
Facility Name
San Agustin
City
Avilés
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roi Bangueses
Facility Name
Centro Medico Teknon
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordi Palet
Facility Name
Clinic
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manel Sabate
Facility Name
Consorci Sanitari Integral
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Freixa
Facility Name
Germans Trias i Pujol
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cosme García
Facility Name
H. Vall d´Hebron
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose A. Barrabes
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandro Sionis
Facility Name
Hospital Universitario de Bellvitge
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Ariza
Facility Name
Hospital de Basurto
City
Bilbao
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abel Andres
Facility Name
Hospital Universitario de Burgos
City
Burgos
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Angel Perez
Facility Name
H. Santa Lucía
City
Cartagena
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isidro Hernandez
Facility Name
Hosptial Universitario Reina Sofia
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Anguita
Facility Name
Hospital de Denia
City
Denia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfonso Valle
Facility Name
Hospital universitario de Elche
City
Elche
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Morillas
Facility Name
Hospital Universitario de Vinalopo
City
Elche
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Arroyo
Facility Name
H.Universitario de Elda
City
Elda
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Paris
Facility Name
Hospital Arquitecto Macide
City
Ferrol
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro Rodriguez
Facility Name
Hospital Galdakao Usansolo
City
Galdakao
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Navarrete
Facility Name
Cabueñes
City
Gijón
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iñigo Lozano
Facility Name
Hospital San Cecilio
City
Granada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Concha Correa
Facility Name
Hospital Virgen de las Nieves
City
Granada
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Antonio Ramirez
Facility Name
Complejo Hospitalario Universitario de Jaen
City
Jaén
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Fernandez
Facility Name
Complejo hospitalario universitario a Coruña
City
La Coruña
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose M Vazquez
Facility Name
Complejo Hospitalario Universitario Insular Materno Infantil
City
Las Palmas De Gran Canaria
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efrén Martinez
Facility Name
Hospital Universitario de Arnau de Vilanova
City
Lerida
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomás Querol
Facility Name
Hospital de Leon
City
León
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Fernandez
Facility Name
Lucus Augusti
City
Lugo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Juanatey
Facility Name
Fundación Jiménez Díaz University Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Gomez-Talavera, MD
Email
sandra.gomezt@quironsalud.es
First Name & Middle Initial & Last Name & Degree
María Lopez-Alvarez, RN
Email
mlalvarez@quironsalud.es
First Name & Middle Initial & Last Name & Degree
Borja Ibanez, MD PhD FESC
Facility Name
Clinica La Luz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Martin Reyes
Facility Name
Hospital 12 de Octubre
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hector Bueno
Facility Name
Hospital Clinico
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Fernandez Ortiz
Facility Name
Hospital Gregorio Marañon
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Fernadez Aviles
Facility Name
Hospital Quirón Pozuelo
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ines García Lunar
Facility Name
Ruber Internacional
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Alegria
Facility Name
Ruber Juan Bravo
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonzalo Pizarro
Facility Name
Hospital de Manresa
City
Manresa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel Vazquez
Facility Name
Hospital Alvarez Buylla
City
Mieres
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Renilla
Facility Name
Hospital Clinico Universitario Virgen de la Arrixaca
City
Murcia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domingo Pascual
Facility Name
Hospital regional Universitario de Malaga
City
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel de Mora
Facility Name
Rey Juan Carlos
City
Móstoles
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Sanz
Facility Name
Hospital Universitario Central Asturias
City
Oviedo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rozado
Facility Name
Son Espases
City
Palma De Mallorca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaume Pons
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pablo Bazal
Facility Name
Montecelo
City
Pontevedra
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Díaz
Facility Name
Clinico Universitario de Salamanca
City
Salamanca
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Luis Sanchez
Facility Name
Marques de Valdecilla
City
Santander
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose María de la Torre
Facility Name
Complejo hospitalario universitario de Santiago
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J Ramon Juanatey
Facility Name
H. Virgen del Rocio
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Maria Campos
Facility Name
Virgen de la Macarena
City
Sevilla
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Hidalgo
Facility Name
Hospital Universitari Joan XXIII
City
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Bardaji
Facility Name
Hospital Universitario Sant Joan de Reus
City
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josep M Alegret
Facility Name
Complejo hospitalario Universitario de Canarias
City
Tenerife
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Dominguez
Facility Name
Hospital General de La Palma
City
Tenerife
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Jose Jaimes Vivas
Facility Name
Nuestra Señora de la Candelaria
City
Tenerife
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Hernandez
Facility Name
Hospital Universitario de Torrejon
City
Torrejón De Ardoz
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Ruiz
Facility Name
Hospital Universitario de Torrevieja
City
Torrevieja
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Torres
Facility Name
H. Verge de la Cinta
City
Tortosa
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delicia Gentille
Facility Name
Hospital Infanta Elena
City
Valdemoro
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petra Sanz
Facility Name
Hospital Clinico
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Sanchis
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaume Aguero
Facility Name
Hospital universitario doctor Peset
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Mora
Facility Name
IMED Valencia
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Fabregat
Facility Name
Hospital Clinico universitario de Valladolid
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto San Roman
Facility Name
Río Hortega
City
Valladolid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Jesus Rollan
Facility Name
Alvaro Cunqueiro
City
Vigo
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Raposeiras
Facility Name
Hospital General de Villalba
City
Villalba
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Navarro
Facility Name
Hospital de Xativa
City
Xàtiva
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Sanchez Torrijos
Facility Name
Miguel Servet
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosario Ortas
Facility Name
San Juan de la Cruz
City
Úbeda
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Luis Bonilla

12. IPD Sharing Statement

Citations:
PubMed Identifier
34351426
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.
Results Reference
background

Learn more about this trial

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

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