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

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Humphries, SophiaKarolinska Institutet,Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, 23100, Karolinska Institute , 141 83 Huddinge , Sweden (author)

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

Article/chapterEnglish2023

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Oxford University Press,2023
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LIBRIS-ID:oai:DiVA.org:uu-508389
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-508389URI
https://doi.org/10.1093/ehjopen/oead036DOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:237265820URI

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Language:English
Summary in:English

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Subject category:art swepub-publicationtype

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AimsMost 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 resultsThe 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.ConclusionData 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 registrationEudra CT number, 2017-002336-17; Clinical trial.gov identifier, NCT03278509

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Mars, KatarinaKarolinska Institutet,Department of Clinical Science and Education, Division of Cardiology, Karolinska Institute , Stockholm , Sweden (author)
Hofmann, RobinKarolinska Institutet,Department of Clinical Science and Education, Division of Cardiology, Karolinska Institute , Stockholm , Sweden (author)
Held, Claes,1956-Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi(Swepub:uu)clahe947 (author)
Olsson, Erik,1967-Uppsala universitet,Hälsovetenskap och e-hälsa(Swepub:uu)erols031 (author)
Karolinska InstitutetDepartment of Neurobiology, Care Sciences and Society, Division of Physiotherapy, 23100, Karolinska Institute , 141 83 Huddinge , Sweden (creator_code:org_t)

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In:European Heart Journal Open: Oxford University Press3:32752-4191

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