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BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function

Study acronym: BETAMI
StatusActive, Not Recruiting
PhasePhase 4
Started2018-10-01
View on ClinicalTrials.gov ↗

Amendment history

2025-06-04
Study Status, Study Description, Outcome Measures v8
Secondary endpoints20 to 18 entries
Malignant ventricular arrhythmia Resuscitatedarrhythmias including resuscitated cardiac arrest Hospitalization orof outpatientcardiac visit for new-onset or dysregulated diabetesorigin
Primary endpoints1 entry, revised
[...] rization, ischemic stroke, malignant ventricular arrhythmia orincluding resuscitated cardiac arrest of cardiac origin
Study description+750 characters
[...] 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 red [...] k of all-cause death, recurrent MI, incident heart failure, unplanned coronary revascularization, ischemic stroke, or malignant ventricular arrhythmia orincluding resuscitated cardiac arrest of card [...] [...]
2025-04-04
Study Status v7
Primary completion dateestimated 2025-04-01→confirmed 2025-04-04
Completion date2034-12-10→2035-12-10
2025-03-30
Study Status, Document Section v6
Re-verified, no change to tracked fields
2024-12-03
Study Status v5
Primary completion date2024-12-10→2025-04-01
2024-02-29
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 2900→confirmed 2895
Study sitesdetails revised at 20 of 20 sites
Show 3 earlier versions
2024-01-02
Study Status, Sponsor/Collaborators, Study Description, Study Design, Outcome Measures, Contacts/Locations, Document Section v3
Primary completion date2022-10-01→2024-12-10
Completion date2023-10-01→2034-12-10
Enrollment target10000→2900
Study sites4→20
Secondary endpoints5 to 20 entries
Non-fatalRecurrent MI VentricularMalignant ventricular arrhythmia Hospitalization or outpatient consultation for incident heart failure Unplanned coronary revascularization Ischemic stroke Resuscitated cardiac arrest Hospitalization for stable and unstable angina Hospitalization for atrial fibrillation, atrial flutter or other atrial tachyarrhythmias Hospitalization for bradycardia, syncope or implantation of pacemaker Hospitalizat [...]
Primary endpoints1 entry, revised
Time to theA composite of death of any cause, and non-fatalrecurrent myocardial infarction, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia or resuscitated cardiac arrest
Study description+2,226 characters
[...] uch prescription. Subjects will be followed up for at least 26 months (median 3 years) with respect to the primary and secondary endpoints. The pr [...] whether oral BB therapy reduces the risk of all-cause death, recurrent MI, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia or non-fatalresuscitated MIcardiac arrest compared to no such therapy, in patients with AMI treated w [...] rimary end-point separately, compared to no such therapy To studyassess whetherclinical oraloutcomes linked BB therapy reducesin the riskfollowing ofsubgroups: hospitalization [...]
Collaborators9 to 14 entries
DrammenVestre sykehusViken Hospital Trust FeiringklinikkenNorwegian University of Science and Technology Sykehuset Innlandet HF Nordlandssykehuset HF Lovisenberg Diakonale Hospital Diakonhjemmet Hospital Ostfold Hospital Trust
2018-10-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-09-06→2022-10-01
Completion date2023-09-06→2023-10-01
Start dateestimated 2018-09-06→confirmed 2018-10-01
Study sites0→4
2018-09-04
Study Status, Document Section v1
Re-verified, no change to tracked fields
2018-08-23
Original filing
The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).
Trial Details
NCT Number NCT03646357
Lead Sponsor Oslo University Hospital
Collaborators: Vestre Viken Hospital Trust, The Hospital of Vestfold, University of Oslo, Helse Stavanger HF, Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway, Sorlandet Hospital HF, Norwegian University of Science and Technology, Sykehuset Innlandet HF, Nordlandssykehuset HF, Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital, Ostfold Hospital Trust
Conditions Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Enrollment 2,895 participants
Start Date 2018-10-01
Primary Completion 2025-04-04 (estimated)
Study Completion 2035-12-10 (estimated)
Updated on ClinicalTrials.gov 2025-06-08