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

June 3, 2025 updated by: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8505

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Borja Ibañez, MD PhD FESC
  • Phone Number: 4302 914501200
  • Email: bibanez@cnic.es

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • Ospedale Civile Santi Antonio e Biagio
      • Ancona, Italy
        • Azienda Ospedaliero Universitaria Ospedali Riuniti
      • Baggiovara, Italy
        • Ospedale Civile
      • Bari, Italy
        • Ospedale San Paolo
      • Bari, Italy
        • Istituto Maugeri IRCCS
      • Bologna, Italy
        • Ospedale Maggiore
      • Caserta, Italy
        • A.O. Sant'Anna e San Sebastiano di Caserta
      • Cortona, Italy
        • Santa Margherita
      • Cremona, Italy
        • Ospedale di Cremona
      • Desio, Italy
        • Ospedale di Desio
      • Empoli, Italy
        • Ospedale San Giuseppe
      • Fidenza, Italy
        • Ospedale di Vaio
      • Foggia, Italy
        • Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia
      • Forlì, Italy
        • Ospedale C.G.Morgagni
      • Grosseto, Italy
        • Ospedale Misericordia
      • Gubbio, Italy
        • Ospedale Gualdo Tadino
      • Legnano, Italy
        • Ospedale Civile di Legnano
      • Melegnano, Italy
        • Ospedale di Vizzolo Predabissi
      • Milano, Italy
        • Ospedale San Paolo
      • Milano, Italy
        • Mario Negri
      • Negrar, Italy
        • Ospedale Sacro Cuore Don Calabria
      • Orbassano, Italy
        • Ospedale San Luigi Gonzaga
      • Osio Sotto, Italy
        • Policlinico San Marco
      • Palermo, Italy
        • Villa Sofía, Palermo
      • Passirana, Italy
        • P.O. di Passirana
      • Piacenza, Italy
        • Ospedale G. da Saliceto ,Piacenza
      • Ravenna, Italy
        • Ospedalel Santa Maria delle Croci
      • Reggio Emilia, Italy
        • Arcispedale S. Maria Nuova
      • Rimini, Italy
        • Ospedale infermi di Rimini
      • Roma, Italy
        • San Filippo Neri
      • Saronno, Italy
        • Presidio Ospedaliero di Saronno
      • Scorrano, Italy
        • Ospedale Veris Delli Ponti
      • Seriate, Italy
        • Ospedale Bolognini
      • Treviglio, Italy
        • Ospedale di Treviglio
      • Udine, Italy
        • Ospedale di Udine
    • Foggia
      • San Severo, Foggia, Italy
        • Teresa Masselli Mascia
  • Spain
      • Alava, Spain
        • Txagorritxu
      • Alcorcón, Spain
        • Fundacion Alcorcon
      • Alcoy, Spain
        • Virgen de los Lirios de Alcoy
      • Alicante, Spain
        • H. San Juan
      • Andújar, Spain
        • Hospital Alto del Gualdalquivir
      • Avilés, Spain
        • San Agustin
      • Barcelona, Spain
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain
        • Centro Medico Teknon
      • Barcelona, Spain
        • Consorci Sanitari Integral
      • Barcelona, Spain
        • H. Vall d´Hebron
      • Barcelona, Spain
        • Clinic
      • Barcelona, Spain
        • Germans Trias I Pujol
      • Bilbao, Spain
        • Hospital de Basurto
      • Burgos, Spain
        • Hospital Universitario de Burgos
      • Cartagena, Spain
        • H. Santa Lucía
      • Córdoba, Spain
        • Hosptial Universitario Reina Sofia
      • Denia, Spain
        • Hospital de Denia
      • Elche, Spain
        • Hospital Universitario de Vinalopó
      • Elche, Spain
        • Hospital Universitario de Elche
      • Elda, Spain
        • H.Universitario de Elda
      • Ferrol, Spain
        • Hospital Arquitecto Macide
      • Galdakao, Spain
        • Hospital Galdakao Usansolo
      • Gijón, Spain
        • Cabueñes
      • Granada, Spain
        • Hospital San Cecilio
      • Granada, Spain
        • Hospital Virgen de las Nieves
      • Huelva, Spain
        • H.U Juan Ramón Jimenez
      • Jaén, Spain
        • Complejo Hospitalario Universitario de Jaen
      • La Coruña, Spain
        • Complejo Hospitalario Universitario A Coruña
      • Las Palmas De Gran Canaria, Spain
        • Complejo Hospitalario Universitario Insular Materno Infantil
      • Lerida, Spain
        • Hospital Universitario de Arnau de Vilanova
      • León, Spain
        • Hospital de León
      • Lugo, Spain
        • Lucus Augusti
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Clínico
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz University Hospital
      • Madrid, Spain
        • Clinica La Luz
      • Madrid, Spain
        • Hospital Quirón Pozuelo
      • Madrid, Spain
        • Ruber Internacional
      • Madrid, Spain
        • Ruber Juan Bravo
      • Madrid, Spain
        • CNIC
      • Manresa, Spain
        • Hospital de Manresa
      • Mieres, Spain
        • Hospital Alvarez Buylla
      • Murcia, Spain
        • Hospital Clínico Universitario Virgen de la Arrixaca
      • Málaga, Spain
        • Hospital Regional Universitario de Málaga
      • Móstoles, Spain
        • Rey Juan Carlos
      • Oviedo, Spain
        • Hospital Universitario Central Asturias
      • Palma De Mallorca, Spain
        • Son Espases
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Pontevedra, Spain
        • Montecelo
      • Salamanca, Spain
        • Clinico Universitario de Salamanca
      • Santander, Spain
        • Marques de Valdecilla
      • Santiago De Compostela, Spain
        • Complejo Hospitalario Universitario de Santiago
      • Sevilla, Spain
        • H. Virgen del Rocío
      • Sevilla, Spain
        • Virgen de la Macarena
      • Tarragona, Spain
        • Hospital Universitari Joan XXIII
      • Tarragona, Spain
        • Hospital Universitario Sant Joan de Reus
      • Tenerife, Spain
        • Complejo Hospitalario Universitario de Canarias
      • Tenerife, Spain
        • Hospital General de La Palma
      • Tenerife, Spain
        • Nuestra Señora de la Candelaria
      • Torrejón De Ardoz, Spain
        • Hospital Universitario De Torrejon
      • Torrevieja, Spain
        • Hospital Universitario de Torrevieja
      • Tortosa, Spain
        • H. Verge de la Cinta
      • Valdemoro, Spain
        • Hospital Infanta Elena
      • Valencia, Spain
        • Hospital La Fe
      • Valencia, Spain
        • Hospital Clínico
      • Valencia, Spain
        • Hospital Universitario Doctor Peset
      • Valencia, Spain
        • IMED Valencia
      • Valladolid, Spain
        • Hospital Clínico Universitario de Valladolid
      • Valladolid, Spain
        • Río Hortega
      • Vigo, Spain
        • Alvaro Cunqueiro
      • Villalba, Spain
        • Hospital General de Villalba
      • Zaragoza, Spain
        • Miguel Servet
      • Úbeda, Spain
        • San Juan de la Cruz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: Beta blocker
long-term maintenance beta-blocker therapy
Other Names:
  • atenolol, bisoprolol, carvedilol, metoprolol, nevibolol.
No Intervention: Control (no beta-blocker therapy).
Do not receive beta -blocker therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE)
Time Frame: 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%)
12-54 months since the beginning (median follow up anticipated 3.75 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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
12-54 months since the beginning (median follow up anticipated 3.75 years)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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):
Time Frame: 12-54 months since the beginning (median follow up anticipated 3.75 years)

3.1: Absolute number of patients undergoing a revascularization procedure during follow-up (% from total patients recruited) note: revascularizations that were scheduled at patients' discharge inclusion WILL NOT be considered an event 3.2: absolute number of patients experiencing cardiac death will be added to number of patients experiencing a stroke and to number of patient experiencing a non fatal reinfarction.

If a patient experience more than one of these events, only first event will be added for the sum of events

3.3 3.3.1: Incidence of admission for symptomatic advanced atrioventricular (AV) block (Mobitz II or third degree). Absolute number of patients admitted for symptomatic AV block (% from total patients recruited) 3.3.2: Incidence of hospital admission for stroke: Absolute number of patients admitted for a stroke during follow-up (% from total patients recruited)

3.4 EQ-5D questionnaire (0-100, 100 best) IIEF-5 quest (5-25, 25 best) PHQ-2 questionnaire (0-6, 6 worst)
12-54 months since the beginning (median follow up anticipated 3.75 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Borja Ibañez, MD PhD FESC, CNIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REBOOT-CNIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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