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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    10000
  • sponsor
    Oslo University Hospital
Updated on 14 February 2022
angiography
clot
troponin
ischemia
q waves
bundle branch block
secondary prevention
left bundle branch block
acute myocardial infarction

Summary

The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).

Description

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 2 years with respect to the primary and secondary endpoints.

The primary objective is to test whether oral BB therapy reduces the risk of all-cause death or non-fatal MI compared to no such therapy, in patients with AMI treated with PCI or thrombolysis without reduced LVEF.

The key secondary objectives are:

  • To study whether oral BB therapy reduces the risk of each of the components of the primary end-point separately, compared to no such therapy
  • To study whether oral BB therapy reduces the risk of hospitalization for ventricular arrhythmias or heart failure compared to no such therapy
  • To study whether oral BB therapy reduces the risk of cardiovascular death compared to no such therapy
  • To assess clinical outcomes linked BB therapy including outcomes in treatment subgroups (i.e. doses), STEMI vs. NSTEMI, betablocker-naive patients vs. those who are not, LVEF subgroups (preserved LVEF: 50% vs. mid-range LVEF: 40-49%), drug-related side-effects, drug adherence, cardiovascular risk factors, quality of life, anxiety, depression, symptom burden (angina, dyspnea), sexual dysfunction and sleep disturbance
  • To study sociodemographic, clinical, and psychosocial characteristics (PROMS and clinical data) between the two study arms and in the total sample
  • To conduct cost-utility analysis in relation to quality of life and a health economic evaluation including drug use, health care utilization, employment, income, and benefit take-up
  • To assess study safety

Exploratory objectives:

  • To study the proportion and predictors of non-adherence with BB, statins and other cardiovascular drugs assessed by direct methods quantifying drug concentrations in blood
  • Identify pharmacokinetic, pharmacogenetic and pharmacodynamic markers associated with side-effects and suboptimal response to treatment with cardiovascular drugs

Post-trial objective:

To perform a joint analysis of the data from this study with that of the REDUCE study (Sweden). This analysis will comprise 17000 patients, giving increased power and precision for clinical decisions on both primary and secondary endpoints.

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.

Safety endpoints:

Rate of ventricular arrhythmias, heart failure, new MI or all-cause death 30 days after randomization and rate of new MI or all-cause death after 6 and 18 months

Safety endpoints will be under the responsibility of the primary investigators at all participating centers and collected by:

  • 30 days: direct telephone contact with the patient and from hospital medical records
  • At 6 and 18 months:, safety assessments at the study visits in addition to linkage to the Norwegian Cardiovascular Disease Registry and The Norwegian Population Registry
  • Continuous surveillance of serious adverse events (SAEs)

Details
Condition Acute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction
Treatment Non-betablocker, Betablocker
Clinical Study IdentifierNCT03646357
SponsorOslo University Hospital
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

To be eligible for inclusion in the study, subjects must fulfill the following
criteria at
inclusion
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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