Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Conditions
Brief summary
Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with myocardial infarction and normal heart function. The aim of this study is to determine whether long-term treatment with oral beta-blockade in patients with myocardial infarction and preserved left ventricular systolic ejection fraction reduces the composite of death of any cause or new myocardial infarction..
Detailed description
REDUCE-SWEDEHEART is designed as a registry-based, randomized, parallel, open-label, multicenter trial. Patients, day 1-7 after myocardial infarction, who have undergone a coronary angiography and with preserved left ventricular systolic ejection fraction will be randomized to either oral beta-blockade (see Intervention for detailed description) at a dose according to the treating physician, or no beta-blockade. To allow quick inclusion the randomization module will be accessible by a simple web-based log-in procedure. Concomitantly, all baseline data about each individual patient will be collected from the SWEDEHEART registry. Patients will then be followed regarding all-cause mortality, myocardial infarction, heart failure, atrial fibrillation, and patient-related outcome measures (for a subgroup of patients). Patients that are eligible but not included in REDUCE-SWEDEHEART will also be followed regarding chosen treatment and the primary and secondary endpoints. Follow-up will continue until 379 primary endpoints have been observed (endpoint driven). All analyses will be performed on the intention-to-treat set, defined as all intentionally randomized patients, by randomized treatment. The primary endpoint is death or new MI. Information about death will be obtained from the Swedish population registry. Information regarding new myocardial infarction during hospitalization and readmission because of myocardial infarction or other outcome (secondary outcomes, see section below), will be obtained from the SWEDEHEART-registry (for myocardial infarction) and the patient registry of the National board of health and welfare.
Interventions
DRUGMetoprolol Succinate
Eligible patients randomized to active treatment will receive long-term oral beta-blockade (metoprolol succinate or bisoprolol).
DRUGBisoprolol
Please see the section above.
Sponsors
Uppsala University
The Swedish Research Council
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A registry-based, randomized, parallel, open-label, multicenter trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Undergone coronary angiography 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the composite of death of any cause or MI | through study completion, an average of 3 year | Time to the composite of death of any cause or MI on an intention to treat basis (ITT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart failure | through study completion, an average of 3 year | Time to hospital readmission due to heart failure (primary \[main\] diagnosis) |
| Asthma or Chronic Obstructive Pulmonary Disease | through study completion, an average of 3 year | Time to hospital readmission due to asthma or chronic obstructive pulmonary disease (primary \[main\] diagnosis) |
| Stroke | through study completion, an average of 3 year | Time to hospital readmission due to stroke (primary \[main\] diagnosis) |
| Health related quality of life (HRQOL) | Estimated maximal follow-up for each patient for this outcome is 1 year. | Health related quality of life (HRQOL) measured by EQ-5D in patients younger than 75 years of age |
| Health care costs | through study completion, an average of 3 year | Health care cost analysis concerning the use beta-blocker treatment |
| All-cause death | through study completion, an average of 3 year | Time to the individual component of the primary endpoint of any cause of death. |
| Myocardial infarction | through study completion, an average of 3 year | Time to the individual component of the primary endpoint of MI. |
| Cardiovascular death | through study completion, an average of 3 year | Time to cardiovascular death. |
| Atrial fibrillation | through study completion, an average of 3 year | Time to hospital readmission due to atrial fibrillation (primary \[main\] diagnosis) |
| Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker | through study completion, an average of 3 year | Time to hospital readmission due to bradycardia or advanced AV-block or hypotension or syncope or need for pacemaker (primary \[main\] diagnosis) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Anxiety | 8 weeks and 12 months after randomization | Cardiac Anxiety measured by Cardiac Anxiety Questionnaire (CAQ) |
| Sexual function | 8 weeks and 12 months after randomization | Sexual function measured by Arizona Sexual Experiences Scale (ASEX) |
| Wellbeing | 8 weeks and 12 months after randomization | Wellbeing measured by WHO-5 Wellbeing Index |
| Anxiety and depression | 8 weeks and 12 months after randomization | Anxiety and depression measured by Hospital Anxiety and Depression Scale (HADS) |
Countries
Sweden
Outcome results
None listed