宽松的心率控制与严格的心率控制治疗心房颤动的随机临床试验方案：丹麦心房颤动（DanAF）研究。
Lenient rate control versus strict rate control for atrial fibrillation: a protocol for the Danish Atrial Fibrillation (DanAF) randomised clinical trial.
机构信息
Department of Internal Medicine - Cardiology Section, Holbaek Hospital, Holbaek, Region Zealand, Denmark
Department of Regional Health Research, University of Southern Denmark Faculty of Health Sciences, Odense, Denmark.
出版信息
BMJ Open. 2021 Mar 31;11(3):e044744. doi: 10.1136/bmjopen-2020-044744.
INTRODUCTION
Atrial fibrillation is the most common heart arrhythmia with a prevalence of approximately 2% in the western world. Atrial fibrillation is associated with an increased risk of death and morbidity. In many patients, a rate control strategy is recommended. The optimal heart rate target is disputed despite the results of the the RAte Control Efficacy in permanent atrial fibrillation: a comparison between lenient vs strict rate control II (RACE II) trial.Our primary objective will be to investigate the effect of lenient rate control strategy (<110 beats per minute (bpm) at rest) compared with strict rate control strategy (<80 bpm at rest) on quality of life in patients with persistent or permanent atrial fibrillation.
METHODS AND ANALYSIS
We plan a two-group, superiority randomised clinical trial. 350 outpatients with persistent or permanent atrial fibrillation will be recruited from four hospitals, across three regions in Denmark. Participants will be randomised 1:1 to a lenient medical rate control strategy (<110 bpm at rest) or a strict medical rate control strategy (<80 bpm at rest). The recruitment phase is planned to be 2 years with 3 years of follow-up. Recruitment is expected to start in January 2021. The primary outcome will be quality of life using the Short Form-36 (SF-36) questionnaire (physical component score). Secondary outcomes will be days alive outside hospital, symptom control using the Atrial Fibrillation Effect on Quality of Life, quality of life using the SF-36 questionnaire (mental component score) and serious adverse events. The primary assessment time point for all outcomes will be 1 year after randomisation.
ETHICS AND DISSEMINATION
Ethics approval was obtained through the ethics committee in Region Zealand. The design and findings will be published in peer-reviewed journals as well as be made available on ClinicalTrials.gov.
TRIAL REGISTRATION NUMBER
NCT04542785.
简介
心房颤动是最常见的心律失常，西方世界的患病率约为 2%。心房颤动与死亡和发病率增加有关。在许多患者中，建议采用心率控制策略。尽管 RAte Control Efficacy in permanent atrial fibrillation：a comparison between lenient vs strict rate control II（RACE II）trial 的结果存在争议，但最佳心率目标仍存在争议。
我们的主要目标将是研究宽松的心率控制策略（休息时<110 次/分钟）与严格的心率控制策略（休息时<80 次/分钟）对持续性或永久性心房颤动患者生活质量的影响。
方法和分析
我们计划进行一项两组、优效性随机临床试验。将从丹麦三个地区的四家医院招募 350 名持续性或永久性心房颤动的门诊患者。参与者将按 1:1 随机分为宽松的药物心率控制策略（休息时<110 次/分钟）或严格的药物心率控制策略（休息时<80 次/分钟）。招募阶段计划为 2 年，随访 3 年。预计将于 2021 年 1 月开始招募。主要结局将使用健康调查简表 36 项（SF-36）问卷（生理成分评分）评估生活质量。次要结局将评估天数、心房颤动对生活质量的影响（使用心房颤动效应生活质量问卷）、SF-36 问卷（心理成分评分）评估生活质量以及严重不良事件。所有结局的主要评估时间点为随机分组后 1 年。
伦理和传播
泽兰地区伦理委员会已批准该研究。设计和发现将在同行评议期刊上发表，并在 ClinicalTrials.gov 上提供。
试验注册号
NCT04542785。
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