OBJECTIVE: Cardiac anxiety (CA) is common and has been associated with increased morbidity and mortality in patients after acute myocardial infarction (AMI). While beta-blockers are widely used in secondary prevention after AMI and have proven anxiolytic effects among psychiatric patients, little is known of their effect on CA among AMI-patients. This study aimed to investigate the effect of beta-blockers on CA in post-AMI patients with preserved cardiac function. METHODS: In this parallel-group, open-label, registry-based randomized clinical trial, assessments with the Cardiac Anxiety Questionnaire (CAQ) were obtained at hospitalization and at two follow-up points (6-10 weeks and 12-14 months) after AMI. Analyses were based on the intention-to-treat (ITT) principle using multiple linear regression, calculating both short- and long-term effects. Stratified analyses were also conducted in groups with low, moderate and high baseline values on the CAQ. RESULTS: From August 2018 through June 2022, 806 patients were enrolled. In the main analysis, no treatment effect of beta-blocker on CA was observed at either follow-up. In stratified analyses, the levels of CA symptoms were lower for those randomized to beta-blocker treatment in the group with moderate baseline CA, at follow-up 2 (β = -0.12
95 % CI -0.22, -0.02
P = 0.016). CONCLUSIONS: This trial found no evidence of an effect of beta-blockers on CA among AMI-patients with preserved cardiac function. However, lacking information on beta-blocker adherence limits the possibility of drawing firm conclusions. Furthermore, there might be a differential effect among patients depending on their baseline CA level, as patients with moderate baseline CA randomized to beta-blockers reported lower CA during follow-up than controls.