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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Ejection Fraction (BETAMI)

Alternative title: Betablokkere etter akutt hjerteinfarkt hos pasienter uten redusert venstre hjertekommarfunksjon

Awarded: NOK 11.9 mill.

Acute heart attack is the leading cause of illness and death in Norway and globally. BETAMI is a large study investigating the effect of treating patients with the drug betablockers after an acute heart attack. Betablockers have been used to prevent further cardiovascular events (secondary prevention) following a heart attack for more than 30 years. Since then the treatment after a heart attack has changed drastically, both in the acute course (implementation of acute coronary reperfusion/revascularization) and afterwards to prevent further problems (secondary prevention with blood-thinners and cholesterol-lowering drugs). Therefore, it is important to re-assess the continuous use of betablockers following an acute heart attack. Eligible participants will be randomised to receive either betablocker treatment or no such treatment. All other preventive medication will be prescribed as usual. In all, we plan to include 5000 patients from all major hospitals and some local hospitals in Norway. So far, we have enrolled 2000 patients. The recruitment of participants to the study has been good also during the COVID-19 pandemic. All participants will be followed-up for a mean 3 years via national registries. Participants are also asked to complete a questionnaire before leaving the hospital, after 30-days and every 6 months related to lifestyle behaviour, medication, quality of life, stress and perceived betablocker related adverse effect. In addition, we are collecting blood samples from some participants for drug analyses. BETAMI will answer whether betablocker still protects against new cardiovascular events and death following a heart attack. For further information on the BETAMI-study, please see the study?s website

BETAMI is a randomized controlled multi-center superiority study designed and powered to provide a definite answer to whether ß-blocker treatment still improves clinical outcome for the large numbers of patients that suffer a myocardial infarction (MI). After more than thirty years of improved care, ß-blockers are prescribed as they were decades ago. BETAMI draws into question if ß-blockers give a net health benefit in contemporary reperfused post-MI patients without evidence of heart failure. BETAMI will individualize ß-blocker treatment: The clinical, psychosocial, health economic, and pharmacological study results combined will certainly contribute to more personalized and cost-effective secondary preventive treatment, monitoring and follow-up care for one of the leading and growing chronic diseases worldwide. BETAMI will perform: -Important outcome analyses -A comprehensive health-economic evaluation by linking study data to the unique national registries in Norway -Patient Reported Outcome Measures (PROMS) analyses for new and requested knowledge about symptom burden, psychosocial factors, quality of life, lifestyle behavior and rehabilitation -Drug metabolism/genetic analyses of ß-blocker therapy and other cardiovascular drugs related to treatment effect, side-effects and adherence (by novel biochemical methods) BETAMI is one of the largest and most ambitious patient-related clinical research projects ever performed in Norway. BETAMI has strong interdisciplinary study organization with participants from all large cardiac centers in Norway. BETAMI results will affect current practice and thus have major implications for patients and treating physicians, as well as for stakeholders and authorities that organize and fund secondary healthcare services. BETAMI will ensure that MI patients receive high-quality and reliable and personalized diagnostics, treatment and rehabilitation throughout their disease trajectory as called for in the BEHANDLING program.


BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering