Long-term treatment with beta-blockers in patients with myocardial infarction and preserved ejection fraction.
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: Metoprolol succinate
Other descriptive name: METOPROLOL SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: not less then
Concentration n
Sponsors
Department of Clinical Sciences, Danderyd Hospital, Karolinska Intitutet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age = 18 years. 2.Day 1-7 after MI as defined by the universal definition of MI, type 1, included in the SWEDEHEART registry. 3.Coronary angiography performed during hospitalization. 4.Obstructive coronary artery disease documented by coronary angiography, i.e. stenosis = 50 %, FFR = 0.80 or iFR = 0.89 in any segment at any time point before randomization. 5.Echocardiography performed after the MI showing a normal ejection fraction (EF=50%). 6.Written informed consent obtained 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 3500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3500
Exclusion criteria
Exclusion criteria: 1.Any condition that may influence the patient’s ability to comply with study protocol. 2.Contraindications for beta-blockade 3.Indication for beta-blockade other than as secondary prevention according to the treating physician Thus, use of oral beta-blockade on admission is not per se an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction reduces the composite of death of any cause or new MI ;Secondary Objective: To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction reduces: -All-cause mortality. -Cardiovascular mortality. -New MI. -Readmission because of atrial fibrillation. -Readmission because of heart failure. To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction influences the risk of readmission to hospital because of: -Bradycardia, Av-block II-III, hypotension, syncope or need for pacemaker. -Asthma or chronic obstructive pulmonary disease. -Stroke. To determine whether long-term treatment with oral beta-blockade in patients with MI and preserved LV systolic ejection fraction affects PROMs and Health care costs in patients registered in SEPHIA;Primary end point(s): Time to the composite of death of any cause or MI ;Timepoint(s) of evaluation of this end point: Time to event | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a All-cause death b Cardiovascular death c MI d Atrial fibrillation (primary [main] diagnosis) e Heart failure (primary [main] diagnosis) f Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker g Asthma or Chronic Obstructive Pulmonary Disease (primary [main] diagnosis) h Stroke i PROMs: symptoms (angina, dyspnea), functional status (CCS class and NYHA class) and health related quality of life (EQ-5D) after 6-10 weeks and after 1 year of treatment. Health related quality of life (HRQOL) measured by EQ-5D in patients younger than 75 years of age. Health care costs ;Timepoint(s) of evaluation of this end point: a-c Time to event d-h Time to admission to hospital i After 6-10 weeks and after 1 year of treatment. | — |
Countries
Estonia, Sweden
Contacts
Public ContactTomas Jernberg
Karolinska Institutet
Outcome results
None listed