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. 2023 Apr 10;3(3):oead036.
doi: 10.1093/ehjopen/oead036. eCollection 2023 May.

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

Sophia Humphries  1 , Katarina Mars  2 , Robin Hofmann  2 , Claes Held  3   4 , Erik M G Olsson  5
Affiliations

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

Sophia Humphries et al. Eur Heart J Open. .

Abstract

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.

Keywords: Adrenergic beta-antagonist; Digital data collection; Myocardial infarction; Nationwide register data; Quality of life; Randomized clinical trial.

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Conflict of interest statement

Conflict of interest: No relationship with industry or conflict of interest relevant for this trial were reported.

Figures

Graphical abstract
Graphical abstract
Figure 1
Figure 1
Flow chart of the first 100 patients recruited and followed up across two time points.
See this image and copyright information in PMC

References

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