Myocardial Infarction
Conditions
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).
Interventions
DRUGBeta blocker
long-term maintenance beta-blocker therapy
Sponsors
Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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): | 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) |
Countries
Italy, Spain
Outcome results
None listed