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

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ClinicalTrials.gov Identifier: NCT03596385
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : March 25, 2022
Sponsor:
Information provided by (Responsible Party):
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

Study Description
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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).

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Beta blocker Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion
Actual Study Start Date : October 31, 2018
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : November 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Arm Intervention/treatment
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 Name: atenolol, bisoprolol, carvedilol, metoprolol, nevibolol.
No Intervention: Control (no beta-blocker therapy).
Do not receive beta -blocker therapy


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of the composite of "all-cause death, nonfatal reinfarction, or heart failure hospitalization" (MACE) [ Time Frame: 24-36 months since the beginning (median follow up anticipated 2.75 months) ]

    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. 1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality. [ Time Frame: 24-36 months since the beginning (median follow up anticipated 2.75 months) ]

    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



Other Outcome Measures:
  1. 1) Incidence of subsequent revascularizations. 2) Incidence of ICD (including CRT) insertion. [ Time Frame: 24-36 months since the beginning (median follow up anticipated 2.75 months) ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03596385


Contacts
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Contact: Borja Ibañez, MD PhD FESC 914501200 ext 4302 bibanez@cnic.es
Contact: Noemi Escalera 914501200 ext 5401 nescalera@cnic.es

Locations
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Sponsors and Collaborators
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Investigators
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Principal Investigator: Borja Ibañez, MD PhD FESC CNIC
More Information
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Responsible Party: Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
ClinicalTrials.gov Identifier: NCT03596385    
Other Study ID Numbers: REBOOT-CNIC
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: March 25, 2022
Last Verified: January 2022

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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
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Metoprolol
Atenolol
Carvedilol
Bisoprolol
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
 Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents