Overview
BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2034-12-10
2034-12-10
Target enrollment:
0
0
Participant gender:
All
All
Summary
The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Oslo University HospitalCollaborators:
Diakonhjemmet Hospital
Haukeland University Hospital
Helse Stavanger HF
Lovisenberg Diakonale Hospital
Nordlandssykehuset HF
Norwegian University of Science and Technology
Ostfold Hospital Trust
Sorlandet Hospital HF
St. Olavs Hospital
Sykehuset Innlandet HF
The Hospital of Vestfold
University Hospital of North Norway
University of Oslo
Vestre Viken Hospital TrustTreatments:
Adrenergic beta-Antagonists
Criteria
Inclusion CriteriaTo be eligible for inclusion in the study, subjects must fulfill the following criteria at
inclusion:
- 18 years or older
- Diagnosed with an acute MI type I according to the "Universal Definition of MI"
(Defined as a detection of a rise and/or fall of cardiac biomarker value, preferably
troponin, with at least one value above the 99th percentile upper reference limit and
with at least one of the following; a) symptoms of ischemia, b) new or presumed new
significant ST-segment-T wave changes or new left bundle branch block, c) development
of pathological Q waves, d) imaging evidence of new loss of viable myocardium or e)
identification of an intracoronary thrombus by coronary angiogram)
- Must have been treated with PCI or thrombolysis during current hospitalization
- Signed informed consent and expected cooperation of the patient according to ICH/GCP
and national/local regulations
- Have a national personal identification number and not be expected to emigrate during
study
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:
- Arrhythmias
- Hypertension
- Cardiomyopathies
- Clinical diagnosis of heart failure
- LVEF < 40% by echocardiography (by measurement and not only visual assessment for
STEMI patients)
- Left ventricular akinesia in ≥ 3 segments regardless of the LVEF
- Contraindications to betablocker-therapy, including but not limited to:
- Bradyarrhythmias
- Hypotension
- Severe peripheral artery disease
- Previously known side-effects causing withdrawal
- Severe chronic obstructive pulmonary disease
- • Women of childbearing potential (a woman is considered of childbearing
potential, i.e. fertile, following menarche and until becoming post-menopausal
unless permanently sterile)
- Known hypersensitivity to any ingredient of the IMP
- Other, according to the responsible investigator
- End-stage somatic disease with short life expectancy, dementia, psychosis and other
conditions could put the subject at significant risk, confound the study results,
interfere significantly with the subject participation in the study, or rendering
informed consent unfeasible
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