美国密苏里大学堪萨斯分校John A. Spertus等研究人员完成SGLT2抑制剂canagliflozin在心衰中的临床试验。相关论文于2022年2月28日在线发表于国际学术期刊《自然—医学》。

据研究人员介绍，大型传统临床试验表明，钠-葡萄糖协同转运体2抑制剂可改善心力衰竭和射血分数降低（HFrEF）患者以及心力衰竭和射血分数保留（HFpEF）患者的症状。

在新冠病毒大流行的情况下，研究人员试图在一种新型的试验中证实这些好处，该试验以病人为中心，完全以远程方式进行。在CHIEF-HF试验（NCT04252287）中，476名HF参与者，无论EF或糖尿病状况如何，都被随机分配到100毫克的canagliflozin或安慰剂。由于赞助商的优先事项发生变化，招募工作提前停止，但没有取消盲法。

主要结果是12周时堪萨斯城心肌病调查表总症状评分（KCCQ TSS）的变化。canagliflozin的12周KCCQ TSS变化比安慰剂高4.3分（95%置信区间，0.8-7.8；P=0.016），达到主要终点。在HFpEF和HFrEF的参与者以及有无糖尿病的参与者中也观察到类似的效果，表明无论EF或糖尿病状况如何，canagliflozin都能显著改善HF的症状负担。这项随机、双盲试验在没有医生和患者之间亲自互动的情况下进行，可以作为未来全虚拟临床试验的模式。

附：英文原文

Title: The SGLT2 inhibitor canagliflozin in heart failure: the CHIEF-HF remote, patient-centered randomized trial

Author: Spertus, John A., Birmingham, Mary C., Nassif, Michael, Damaraju, C. V., Abbate, Antonio, Butler, Javed, Lanfear, David E., Lingvay, Ildiko, Kosiborod, Mikhail N., Januzzi, James L.

Issue&Volume: 2022-02-28

Abstract: Large traditional clinical trials suggest that sodium-glucose co-transporter 2 inhibitors improve symptoms in patients with heart failure and reduced ejection fraction (HFrEF) and in patients with heart failure and preserved ejection fraction (HFpEF). In the midst of the Coronavirus Disease 2019 pandemic, we sought to confirm these benefits in a new type of trial that was patient centered and conducted in a completely remote fashion. In the CHIEF-HF trial (NCT04252287), 476 participants with HF, regardless of EF or diabetes status, were randomized to 100mg of canagliflozin or placebo. Enrollment was stopped early due to shifting sponsor priorities, without unblinding. The primary outcome was change in the Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at 12 weeks. The 12-week change in KCCQ TSS was 4.3 points (95% confidence interval, 0.8–7.8; P=0.016) higher with canagliflozin than with placebo, meeting the primary endpoint. Similar effects were observed in participants with HFpEF and in those with HFrEF and in participants with and without diabetes, demonstrating that canagliflozin significantly improves symptom burden in HF, regardless of EF or diabetes status. This randomized, double-blind trial, conducted without in-person interactions between doctor and patient, can serve as a model for future all-virtual clinical trials.

DOI: 10.1038/s41591-022-01703-8

Source: https://www.nature.com/articles/s41591-022-01703-8