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
; 3(3): oead036, 2023 May.
Article
em En
| MEDLINE
| ID: mdl-37265820
ABSTRACT
Aims:
Most cases of acute myocardial infarction (MI) in Sweden are treated with long-term ß-blocker therapy as secondary prevention. Case studies and patient reports have indicated negative effects of ß-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 ß-blockers on these factors. Methods andresults:
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 ß-blockers on self-reported measures of QoL. Following randomized allocation to long-term ß-blocker or no ß-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 ß-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 ß-blocker use. Clinical trial registration Eudra CT number, 2017-002336-17; Clinical trial.gov identifier, NCT03278509.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Aspecto:
Patient_preference
Idioma:
En
Revista:
Eur Heart J Open
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Suécia