A Phase 4 interventional study of Non-betablocker and Betablocker in Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction and ST Elevation Myocardial Infarction, sponsored by Oslo University Hospital. Active, not recruiting at 20 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-08.
Sponsored by Oslo University Hospital · Phase 4, Interventional, and Treatment
The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).
This is a prospective, randomized, open blinded end-point (PROBE) study. Patients with AMI will be randomized 1-8 days following PCI or thrombolysis, and allocated to either prescription of a BB or to no such prescription. Subjects will be followed up for at least 6 months (median 3 years) with respect to the primary and secondary endpoints. The primary end point, the key secondary end points, and most other secondary end points will be analysed and published jointly with data from the 'Danish Trial of Beta-blocker therapy after myocardial infarction without heart failure' (DANBLOCK) (NCT 03778554) (please see below).
The primary objective is to test whether oral BB therapy reduces the risk of all-cause death, recurrent MI, incident heart failure, unplanned coronary revascularization, ischemic stroke, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin compared to no such therapy, in patients with AMI treated with PCI or thrombolysis without reduced LVEF.
The key secondary objectives (planned for the main study) are:
Other secondary objectives (for joint BETAMI-DANBLOCK sub-studies) are:
quality of life, angina, dyspnoea, anxiety, depression, sexual dysfunction or sleep disorders
Exploratory objectives (based on BETAMI data, only):
The primary study end-points will be obtained through linkage to the Norwegian Cardiovascular Disease Registry and The Norwegian Population Registry (Folkeregisteret)
Secondary endpoints will be obtained by linkage to the following national registries: The Norwegian Population Registry (Folkeregisteret), the Cause of Death Registry, the Norwegian Patient Registry, the Norwegian Cardiovascular Disease Registry, the Norwegian Prescription Database, the Norwegian registry for income, the FD-Trygd database (social security micro data for research) and the Control and payment of reimbursements to health service providers (KUHR) database. Further by collecting self-reported questionnaires and a clinical examination with blood sample collection.
Primary safety endpoints:
Other safety endpoints:
Rationale for combining data from the BETAMI study with the DANBLOCK (NCT03778554) study from Denmark: The trials have similar designs, only minor differences in study entry criteria, and were, from the very beginning, coordinated with the aim of conducting sub-studies on pooled data. However, the inclusion- and event rates have been lower than expected in both studies. To enhance feasibility, the final decision was made from both Steering Committees in May 2021 to combine the trials and publish initial results jointly. BETAMI and DANBLOCK will remain separate trials until the end of follow-up, where data from the trials will be combined and main results published together.
Sample size: A total of approximately 2900 patients from BETAMI will be recruited and randomized 1:1 to BB treatment (type and dosage according to treating physician) or no BB treatment within 8 days of MI. The study is event driven and a power calculation for the combined DANBLOCK-BETAMI trial has been performed in which 950 events will provide a power of 80% to detect a true treatment effect equal to a hazard ratio of 1.2 for no beta-blocker therapy. Follow-up: Patients will be followed from the randomization date until end of follow-up. The last patient included will be followed for a minimum of 6 months. Estimated mean (non) treatment duration is 3 (0.5-6) years.
Post-trial objective:
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 2,895 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
To be eligible for inclusion in the study, subjects must fulfill the following criteria at inclusion:
Exclusion Criteria
Study subjects must not meet any of the following criteria:
Having a condition where betablocker-therapy is required, including but not limited to:
Contraindications to betablocker-therapy, including but not limited to:
Previous treatment with a betablocker is not an exclusion criterion for enrollment into the BETAMI study. Enrolled patients can participate in any other study that does not directly alter the effect betablocker treatment
Patients receiving a betablocker. Any other treatment or management is to be given as per usual care.
Drug: Betablocker
No betablocker is given to this arm. Any other treatment or management is to be given as per usual care.
Other: Non-betablocker
No betablocker will be administered. Patients randomized to no beta-blockade will be discouraged to use beta-blockade as long as there is no other indication than strictly secondary prevention after myocardial infarction. Any other treatment or management is to be given as per usual care.
A betablocker will be administered. To reflect contemporary management, for which this study is designed to test, there will not be a defined minimum dosage. The type and dose of BB will be left at the discretion of the PI. Generic drug and accepted dosages will be: * Metoprolol succinate up to a total dose of 200mg daily * Bisoprolol up to a total dose of 10mg daily * Carvedilol up to a total dose of 50mg daily The treating physician will be encouraged to aim for an equipotent dose of 100 mg metoprolol succinate or higher. Any other treatment or management is to be given as per usual care.
A composite of death of any cause, recurrent myocardial infarction, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin
Incidence of combined endpoint from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Recurrent MI
Time to recurrent MI from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
All-cause death
Time to a-cause Death from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Malignant ventricular arrhythmias including resuscitated cardiac arrest of cardiac origin
Time to malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Hospitalization or outpatient consultation for incident heart failure
Time to hospitalization or outpatient consultation for heart failure from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Unplanned coronary revascularization
Time to unplanned coronary revascularization from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Ischemic stroke
Time to ischemic stroke from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Cardiovascular death
Time to cardiovascular death from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Hospitalization for stable and unstable angina
Time to hospitalization for stable and unstable angina from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Hospitalization for atrial fibrillation, atrial flutter or other atrial tachyarrhythmias
Time to hospitalization for atrial fibrillation, atrial flutter or other atrial tachyarrhythmias from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Hospitalization for bradycardia, syncope or implantation of pacemaker
Time to hospitalization for bradycardia, syncope or implantation of pacemaker from randomization. Estimated maximal follow-up for each patient for this outcome I 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease
Time to hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
Time frame: 6 months (minimum) to 6 years (maximum)
Angina symptoms
Canadian Cardiovascular Society (CCS) grading of angina pectoris.
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
Health-related quality of life
Health-related quality of life measured by the Short Form (SF) 12
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
Measures of depression and anxiety
HADS (Hospital Anxiety and Depression Scale)
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
Measures of sexual dysfunction
The International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI)
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
Measures of sleep disorders
Bergen insomnia Scale
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
Measures of sleep disorders
Bergen insomnia Scale and sleep duration
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
Measures of Nightmare Frequency
Nightmare Frequency Questionnaire
Time frame: Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months
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Oslo University Hospital