Key result
Post-MI beta-blocker quality of life trial achieves ~93% questionnaire completion at first follow-up.
Why the study?
Case studies and patient reports indicate negative effects of beta-blockers on quality of life, but no recent large-scale randomized trial has explored these effects in acute MI patients treated with long-term therapy.
Does long-term β-blocker therapy affect self-reported measures of quality of life in patients after acute myocardial infarction?
RCT (n=100)
Open-label, blinded endpoint
Randomized
Yes
Does long-term β-blocker therapy affect self-reported measures of quality of life in patients after acute myocardial infarction?
The RQoL substudy is successfully recruiting to evaluate the impact of long-term beta-blocker therapy on quality of life after myocardial infarction.
Successful early recruitment affirms RCT viability; leaves open definitive long-term beta-blocker effects on post-MI quality of life.
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.
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Humphries et al. (2023) conducted an RCT in Acute myocardial infarction (n=100). Long-term beta-blocker therapy vs. No beta-blocker treatment was evaluated on Self-reported measures of quality of life, sexual functioning, and perceived side effects. Long-term beta-blocker therapy evaluation for quality of life in myocardial infarction successfully recruited its first 100 patients, with 93% completing questionnaires at first follow-up.
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