Saint Luke's Mid America Heart Institute/University of Missouri-Kansas City (J.S., M.K.).
Janssen Scientific Affairs, LLC Titusville, NJ (M.B.,J.W.).
Circ Heart Fail. 2021 Mar;14(3):e007767. doi: 10.1161/CIRCHEARTFAILURE.120.007767. Epub 2021 Mar 16.
The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms.
One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire.
The trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic.
CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04252287.
临床试验的费用要求制定新策略，以有效地生成证据并测试新疗法。在此背景下，我们设计了一项去中心化、以患者为中心的随机临床试验，利用移动技术（而非面对面的现场访视）来测试卡格列净治疗心力衰竭的疗效，无论射血分数或糖尿病状态如何，都可治疗 12 周心力衰竭症状。
将入组 1900 例经病历确认的心力衰竭患者，按射血分数降低（≤40%）或保留（>40%）分层，按 1:1 随机分为每日 100 mg 卡格列净或匹配安慰剂组。主要结局为堪萨斯城心肌病问卷总症状评分的 12 周变化。次要结局为堪萨斯城心肌病问卷的每日步数和其他量表。
该试验正在入组，甚至在 2019 年冠状病毒病（COVID-19）大流行时期也是如此。
CHIEF-HF（卡格列净：心力衰竭对健康状况、生活质量和功能状态的影响）正在为卡格列净的新适应证部署一种去中心化、以患者为中心、随机临床试验的新模式，以改善心力衰竭患者的症状。它可以为使用移动技术和患者报告的结局作为试验的主要临床终点来更具成本效益地测试治疗效果建立一种新模式。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT04252287。
