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; Katarina Mars; Robin Hofmann; Claes Held; Erik M G Olsson

doi:10.1093/ehjopen/oead036

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

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

Authors

Sophia Humphries¹, Katarina Mars², Robin Hofmann², Claes Held^{3

4}, Erik M G Olsson⁵

Affiliations

¹ Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, 23100, Karolinska Institute, 141 83 Huddinge, Sweden.
² Department of Clinical Science and Education, Division of Cardiology, Karolinska Institute, Stockholm, Sweden.
³ Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
⁴ Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
⁵ Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.

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.

Associated data

ClinicalTrials.gov/NCT03278509