用皮下注射呋塞米治疗恶化的心力衰竭，避免住院治疗：试点研究（AT HOME-HF）。

IF 10.3 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

JACC. Heart failure Pub Date : 2024-11-01 DOI:10.1016/j.jchf.2024.07.015

Marvin A. Konstam MD , Joseph Massaro PhD , Ravi Dhingra MD, MPH , Mary Walsh MD , Linda Ordway RN, MS, NP , Michael S. Pursley MD , Dalton S. McLean MD , Sandeep Saha MS , Nicole Close PhD , Jeremy M. Konstam MS , Katherine H. Luepke PharmD, BCPS, CMPP , John F. Mohr PharmD , James E. Udelson MD

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引用次数: 0

摘要

背景需要在慢性心力衰竭（HF）患者不住院的情况下采用治疗方法解决充血恶化问题。目的这项试验性研究评估了新型皮下注射（SC）呋塞米制剂与常规护理相比对充血恶化的门诊患者的治疗效果。通过追踪体重来估计充血缓解情况。主要终点是30天内心血管死亡、心房颤动事件和N末端前B型钠尿肽变化的分级复合胜率。次要终点包括呼吸困难严重程度、功能能力和生活质量。结果34名参与者随机接受呋塞米皮下注射，17名参与者随机接受UC治疗。呋塞米皮下注射可使体重减轻更多：第 3 天，组间最小平方均值变化差为-2.02 千克（95% CI：-3.9 至-0.14；P = 0.035）。呋塞米镇静剂与尿激酶的比值为 1.11（95% CI：0.48-2.50；P = 0.806）。在呼吸困难 7 分评分（P = 0.017）和 6 分钟步行测试（P = 0.032）中，组间最小二乘法均值差异显著，而堪萨斯城心肌病问卷 (KCCQ)-12 总体汇总评分为 9.15（95% CI：1.95-20.3；P = 0.106）。呋塞米钠盐最常见的相关不良事件是输液部位轻微疼痛（11.8%）。在这项试点调查中，复合主要终点并无统计学意义。然而，呼吸困难评分和功能能力的改善以及KCCQ-12评分的良好趋势值得进一步研究，以进一步证明呋塞米钠钠盐作为住院治疗替代方案的临床价值（AT HOME-HF [避免在医院接受呋塞米钠盐治疗心力衰竭充血--试点研究]；NCT04593823）。

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Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure

Background

Therapies are needed to address worsening congestion, without hospitalization, in patients with chronic heart failure (HF).

Objectives

This pilot study assessed outcomes of a novel subcutaneous (SC) furosemide formulation compared to usual care in outpatients with worsening congestion.

Methods

Participants with chronic HF and worsening congestion were randomized open-label 2:1 to SC furosemide compared to usual care (UC). Decongestion was estimated by tracking body weight. The primary endpoint was a win ratio of a 30-day hierarchical composite of cardiovascular death, HF events, and change in N-terminal pro–B-type natriuretic peptide. Secondary endpoints included dyspnea severity, functional capacity, and quality of life.

Results

Thirty-four participants were randomized to SC furosemide and 17 to UC. SC furosemide caused greater reduction in body weight: between-group difference in least square mean change was −2.02 kg at day 3 (95% CI: −3.9 to −0.14; P = 0.035). SC furosemide-to-UC win ratio was 1.11 (95% CI: 0.48-2.50; P = 0.806). Significant between-group least square mean differences favoring SC furosemide occurred in 7-point dyspnea score (P = 0.017) and 6-minute walk test (P = 0.032), with trend in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 Overall Summary Score of 9.15 (95% CI: 1.95-20.3; P = 0.106). The most common related adverse event with SC furosemide was mild infusion site pain (11.8%).

Conclusions

SC furosemide augmented weight loss in patients with HF and worsening congestion. The composite primary endpoint was not statistically significant in this pilot investigation. However, findings of improved dyspnea scores and functional capacity, with favorable trend in KCCQ-12 score, warrant additional investigation to further document the clinical value of SC furosemide as an alternative to hospitalization (AT HOME-HF [Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure—A Pilot Study]; NCT04593823)

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来源期刊

JACC. Heart failure CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

21.20

自引率

2.30%

发文量

164

期刊介绍： JACC: Heart Failure publishes crucial findings on the pathophysiology, diagnosis, treatment, and care of heart failure patients. The goal is to enhance understanding through timely scientific communication on disease, clinical trials, outcomes, and therapeutic advances. The Journal fosters interdisciplinary connections with neuroscience, pulmonary medicine, nephrology, electrophysiology, and surgery related to heart failure. It also covers articles on pharmacogenetics, biomarkers, and metabolomics.