心肌梗死后常规β-受体阻滞剂治疗生活质量(RQoL)的随机评估:一项多中心、前瞻性、随机、开放、盲法终点研究的设计与原理。

European Heart Journal Open Pub Date : 2023-04-10 eCollection Date: 2023-05-01 DOI:10.1093/ehjopen/oead036
Sophia Humphries, Katarina Mars, Robin Hofmann, Claes Held, Erik M G Olsson
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引用次数: 0

摘要

目的:在瑞典,大多数急性心肌梗死(MI)患者都接受长期的 β 受体阻滞剂治疗作为二级预防。病例研究和患者报告显示,β-受体阻滞剂有负面影响,包括抑郁症状、疲劳、性功能障碍和情绪低落,这些都与生活质量(QoL)下降有关。迄今为止,近期还没有大规模的随机试验探讨过 β 受体阻滞剂对这些因素的影响:正在进行的 "心肌梗死后减少使用β-受体阻滞剂的随机评估(REDUCE):生活质量(RQoL)研究 "是一项多中心、前瞻性、随机的预设子研究,旨在评估β-受体阻滞剂对自我报告的生活质量的影响。患者被随机分配到长期β-受体阻滞剂治疗或不使用β-受体阻滞剂治疗后,要完成与QoL、性功能和感知副作用有关的六项基线测量。数据收集可选择通过一个独特而安全的门户网站在线进行,并在两个随访时间点再次重复。招募工作于 2018 年 7 月开始。首批 100 名患者的数据显示,在第一次随访时,93% 的患者完成了问卷调查,而在第二次随访时,这一比例降至 81%。在迄今招募的患者中,超过半数采用了数字数据收集方法:首批 100 名患者的数据表明,研究设计和招募工作取得了成功。临床试验注册:Eudra CT 编号:2017-002336-17;Clinical trial.gov 识别码:NCT03278509。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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.

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.

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.

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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