Treatment with beta-blockers after myocardial infarction without reduced ejection fractio

Phase 1

• Conditions: STEMI or NSTEMI patients being discharged from the index hospitalization with a LVEF>40% without previous heart failure; MedDRA version: 20.0Level: LLTClassification code 10021758Term: Infarct myocardialSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-002485-40-IT
• Lead Sponsor: CENTRO NACIONAL DE INVESTIGACIONES CARDIOVASCULARES CARLOS III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 8468

Inclusion Criteria

1) > 18 years old or 18 years old
2) STEMI or STEMI patient
3) LVEF >40%
4) INFORM CONSENT SIGNED
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6468

Exclusion Criteria

1) Known allergy or intolerance to beta-blockers
2) Absolute contraindication to beta-blocker therapy according to treating physician judge
3) Prior history of HF, Killip class on admission or during hospitalization = II
4) Severe valvular heart disease (> 3+ for aortic or mitral insufficiency, aortic or mitral valve area =1.0 cm2).
5) Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
6) Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
7) Patients participating in other clinical trials.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Incidence rate of the composite of ¿all-cause death, nonfatal reinfarction, or heart failure hospitalization¿.;Secondary Objective: 1) Incidence rate of individual components of the primary outcome. 2) Incidence rate of cardiac mortality. ;Primary end point(s): To assess the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI) with a left ventricular ejection fraction >40%. Beta-blocker treatment will be associated with a 20% reduction in the incidence rate of the primary composite endpoint: incidence rate of the composite of all-cause death, non fatal reinfarction, or heart failure hospitalization”.;Timepoint(s) of evaluation of this end point: Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Incidence rate of individual components of the primary outcome;; Incidence of cardiac mortality.;Timepoint(s) of evaluation of this end point: Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years; Minimum follow-up 2 years, maximum follow-up 3 years. Estimated median follow-up 2.75 years