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达格列净对慢性心力衰竭患者心脏重构的影响:DAPA-MODA 研究。

Impact of dapagliflozin on cardiac remodelling in patients with chronic heart failure: The DAPA-MODA study.

机构信息

Cardiology Department, Hospital Clínico Universitario Virgen de la Arrixaca, Instituto IMIB-Pascual Parrilla, Murcia, Spain.

Medicine Department, Universidad de Murcia, Murcia, Spain.

出版信息

Eur J Heart Fail. 2023 Aug;25(8):1352-1360. doi: 10.1002/ejhf.2884. Epub 2023 Jun 7.

Abstract

AIMS

Dapagliflozin improves the prognosis of patients with heart failure (HF), regardless of left ventricular ejection fraction (LVEF). However, its effect on cardiac remodelling parameters, specifically left atrial (LA) remodelling, is not well established.

METHODS AND RESULTS

The DAPA-MODA trial (NCT04707352) is a multicentre, single-arm, open-label, prospective and interventional study that aimed to evaluate the effect of dapagliflozin on cardiac remodelling parameters over 6 months. Patients with stable chronic HF receiving optimized guideline-directed therapy, except for any sodium-glucose cotransporter 2 inhibitor, were included. Echocardiography was performed at baseline, 30 and 180 days, and analysed by a central core-lab in a blinded manner to both patient and time. The primary endpoint was the change in maximal LA volume index (LAVI). A total of 162 patients (64.2% men, 70.5 ± 10.6 years, 52% LVEF >40%) were included in the study. At baseline, LA dilatation was observed (LAVI 48.1 ± 22.6 ml/m ) and LA parameters were similar between LVEF-based phenotypes (≤40% vs. >40%). LAVI showed a significant reduction at 180 days (-6.6% [95% confidence interval -11.1, -1.8], p = 0.008), primarily due to a decrease in reservoir volume (-13.8% [95% confidence interval -22.5, -4], p = 0.007). Left ventricular geometry improved with significant reductions in left ventricular mass index (-13.9% [95% confidence interval -18.7, -8.7], p < 0.001), end-diastolic volume (-8.0% [95% confidence interval -11.6, -4.2], p < 0.001) and end-systolic volume (-11.9% [95% confidence interval -16.7, -6.8], p < 0.001) at 180 days. N-terminal pro-B-type natriuretic peptide (NT-proBNP) showed a significant reduction at 180 days (-18.2% [95% confidence interval -27.1, -8.2], p < 0.001), without changes in filling Doppler measures.

CONCLUSION

Dapagliflozin administration in stable out-setting patients with chronic HF and optimized therapy results in global reverse remodelling of cardiac structure, including reductions in LA volumes and improvement in left ventricular geometry and NT-proBNP concentrations.

摘要

目的

达格列净可改善心力衰竭(HF)患者的预后,无论其左心室射血分数(LVEF)如何。然而,其对心脏重构参数,特别是左心房(LA)重构的影响尚未得到充分证实。

方法和结果

DAPA-MODA 试验(NCT04707352)是一项多中心、单臂、开放标签、前瞻性和干预性研究,旨在评估达格列净在 6 个月内对心脏重构参数的影响。纳入了接受最佳指南指导治疗但不使用任何钠-葡萄糖共转运蛋白 2 抑制剂的稳定慢性 HF 患者。在基线、30 天和 180 天时进行超声心动图检查,并由中心核心实验室以盲法进行分析,既不了解患者也不了解时间。主要终点是最大左心房容量指数(LAVI)的变化。共有 162 名患者(64.2%为男性,70.5±10.6 岁,52%的 LVEF>40%)纳入研究。基线时观察到 LA 扩张(LAVI 48.1±22.6ml/m2),LA 参数在基于 LVEF 的表型之间相似(≤40%与>40%)。180 天时 LAVI 显著降低(-6.6%[95%置信区间-11.1,-1.8],p=0.008),主要是由于储存容量减少(-13.8%[95%置信区间-22.5,-4],p=0.007)。左心室几何形状得到改善,左心室质量指数(-13.9%[95%置信区间-18.7,-8.7],p<0.001)、舒张末期容积(-8.0%[95%置信区间-11.6,-4.2],p<0.001)和收缩末期容积(-11.9%[95%置信区间-16.7,-6.8],p<0.001)在 180 天时显著降低。180 天时 N 端脑钠肽前体(NT-proBNP)显著降低(-18.2%[95%置信区间-27.1,-8.2],p<0.001),但充盈多普勒测量无变化。

结论

在稳定的慢性 HF 初始患者中使用达格列净并进行最佳治疗可导致心脏结构的全面逆向重构,包括 LA 容积减少以及左心室几何形状和 NT-proBNP 浓度改善。

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