Department of Cardiology, Amsterdam UMC, Amsterdam, The Netherlands.
Netherlands Heart Institute, Utrecht, The Netherlands.
Nat Med. 2024 Oct;30(10):2907-2913. doi: 10.1038/s41591-024-03238-6. Epub 2024 Aug 31.
Guideline-directed medical therapy (GDMT) has clear benefits on morbidity and mortality in patients with heart failure; however, GDMT use remains low. In the multicenter, open-label, investigator-initiated ADMINISTER trial, patients (n = 150) diagnosed with heart failure and reduced ejection fraction (HFrEF) were randomized (1:1) to receive usual care or a strategy using digital consults (DCs). DCs contained (1) digital data sharing from patient to clinician (pharmacotherapy use, home-measured vital signs and Kansas City Cardiomyopathy Questionnaires); (2) patient education via a text-based e-learning; and (3) guideline recommendations to all treating clinicians. All remotely gathered information was processed into a digital summary that was available to clinicians in the electronic health record before every consult. All patient interactions were standardly conducted remotely. The primary endpoint was change in GDMT score over 12 weeks (ΔGDMT); this GDMT score directly incorporated all non-conditional class 1 indications for HFrEF therapy with equal weights. The ADMINISTER trial met its primary outcome of achieving a higher GDMT in the DC group after a follow-up of 12 weeks (ΔGDMT score in the DC group: median 1.19, interquartile range (0.25, 2.3) arbitrary units versus 0.08 (0.00, 1.00) in usual care; P < 0.001). To our knowledge, this is the first multicenter randomized controlled trial that proves a DC strategy is effective to achieve GDMT optimization. ClinicalTrials.gov registration: NCT05413447 .
指南指导下的医学治疗(GDMT)对心力衰竭患者的发病率和死亡率有明显益处;然而,GDMT 的使用率仍然很低。在这项多中心、开放标签、研究者发起的 ADMINISTER 试验中,患有心力衰竭和射血分数降低(HFrEF)的患者(n=150)被随机(1:1)分配接受常规护理或使用数字咨询(DCs)的策略。DC 包含(1)从患者到临床医生的数字数据共享(药物治疗使用情况、家庭测量的生命体征和堪萨斯城心肌病问卷);(2)通过基于文本的电子学习进行患者教育;(3)向所有治疗临床医生提供指南建议。所有远程收集的信息都被处理成一个数字摘要,在每次咨询前都可在电子健康记录中提供给临床医生。所有患者交互都是标准的远程进行的。主要终点是 12 周内 GDMT 评分的变化(ΔGDMT);该 GDMT 评分直接将所有非条件 1 类心力衰竭治疗的适应证纳入其中,权重相等。ADMINISTER 试验达到了其主要结局,即在 12 周的随访后,DC 组的 GDMT 更高(DC 组的 ΔGDMT 评分:中位数 1.19,四分位距(0.25,2.3)任意单位,而常规护理组为 0.08(0.00,1.00);P<0.001)。据我们所知,这是第一个证明 DC 策略可有效实现 GDMT 优化的多中心随机对照试验。ClinicalTrials.gov 注册号:NCT05413447。