Randomized evaluation of routine beta-blocker therapy after myocardial infarction quality of life (RQoL): design and rationale of a multicentre, prospective, randomized, open, blinded endpoint study.

Aims: Most cases of acute myocardial infarction (MI) in Sweden are treated with long-term β-blocker therapy as secondary prevention. Case studies and patient reports have indicated negative effects of β-blockers including symptoms of depression, fatigue, sexual dysfunction, and general low mood, all related to reduced quality of life (QoL). To date, no recent large-scale, randomized trial has explored the effects of β-blockers on these factors. Methods and results: The ongoing Randomized Evaluation of Decreased Usage of beta-bloCkErs after myocardial infarction (REDUCE): quality of life (RQoL) study is a multicentre, prospective, randomized pre-specified substudy aiming to evaluate the effects of β-blockers on self-reported measures of QoL. Following randomized allocation to long-term β-blocker or no β-blocker treatment, patients complete a total of six baseline measures pertaining to QoL, sexual functioning, and perceived side effects. Data collection is optionally carried out online through a unique and secure portal and repeated again at two follow-up time points. Recruitment began in July 2018. Data from the first 100 patients showed that at the first follow-up, 93% had completed the questionnaires, which decreased to 81% at the second follow-up. The method of digital data collection was utilized by over half of the patients recruited so far. Conclusion: Data from the first 100 patients indicate success in terms of study design and recruitment. The RQoL substudy investigates the effects of β-blockers on self-reported measures of QoL in MI patients and will potentially contribute to the limited knowledge of QoL-related side effects reported in conjunction with β-blocker use. Clinical trial registration: Eudra CT number, 2017-002336-17; Clinical trial.gov identifier, NCT03278509.