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自适应伺服通气治疗收缩性心力衰竭患者中枢性睡眠呼吸暂停:SERVE-HF 主要亚研究结果。

Adaptive servo-ventilation for central sleep apnoea in systolic heart failure: results of the major substudy of SERVE-HF.

机构信息

Imperial College London, London, UK.

ResMed Science Centre, ResMed Germany Inc., Martinsried, Germany.

出版信息

Eur J Heart Fail. 2018 Mar;20(3):536-544. doi: 10.1002/ejhf.1048. Epub 2017 Nov 30.

Abstract

AIMS

The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers.

METHODS AND RESULTS

In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers.

CONCLUSION

In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.

摘要

目的

SERVE-HF 试验研究了针对收缩性心力衰竭患者的中枢性睡眠呼吸暂停(CSA)采用适应性伺服通气(ASV)治疗的效果。进行了一项预先计划的子研究,以深入了解 ASV 观察到的效果背后的机制变化,包括评估左心室功能、心室重构以及心脏、肾脏和炎症生物标志物的变化。

方法和结果

在随机分组的 1325 例患者的亚组中,基线时、3 个月和 12 个月时进行了超声心动图、心脏磁共振成像(cMRI)和生物标志物分析。在二次分析中,评估了具有基线和 12 个月值的患者的数据;312 例患者参与了子研究。主要终点为从基线到 12 个月时超声心动图确定的左心室射血分数的变化,ASV 组和对照组之间无显著差异。两组之间在左心室大小、壁厚度、舒张功能或右心室大小和射血分数(超声心动图)以及 cMRI (患者数量较少)的变化方面也无显著组间差异。两组的血浆 N 端脑利钠肽前体浓度均降低,12 个月时的数值相似。心脏、肾脏和全身炎症生物标志物的变化在两组之间无显著差异。

结论

在合并 CSA 的收缩性心力衰竭患者中,与基于指南的医学治疗相比,在 12 个月时,ASV 加用对心脏结构和功能或心脏生物标志物、肾功能和全身炎症无统计学显著影响。SERVE-HF 中报告的心血管死亡率增加可能与不良重塑或心力衰竭恶化无关。

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