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用沙库巴曲缬沙坦(恩格列净)和达格列净优化当代射血分数降低的心力衰竭(HFrEF)药物治疗对心脏磁共振成像(CMR)所显示的左心室逆向重构的影响:ENVI研究

Effect of optimisation to contemporary HFrEF medical therapy with sacubitril/valsartan (Entresto) and dapaglifloziN on left Ventricular reverse remodelling as demonstrated by cardiac magnetic resonance (CMR) Imaging: the ENVI study.

作者信息

Zheng Alice, Adam Robert, Peebles Charles, Harden Stephen, Shambrook James, Abbas Ausami, Vedwan Katharine, Adam Georgina, Haydock Paul, Cowburn Peter, Young Christopher, Long Jane, Walkden Michelle, Smith Simon, Greenwood Elizabeth, Olden Paula, Flett Andrew

机构信息

University Hospital Southampton NHS Foundation Trust, Southampton, UK

University Hospital Southampton NHS Foundation Trust, Southampton, UK.

出版信息

Open Heart. 2024 Dec 2;11(2):e002933. doi: 10.1136/openhrt-2024-002933.

DOI:10.1136/openhrt-2024-002933
PMID:39622578
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11624772/
Abstract

INTRODUCTION

Heart failure with reduced ejection fraction (HFrEF) guidelines recommend 'four pillars' of medical therapy and device therapy if left ventricular ejection fraction (LVEF) remains ≤35% after 3 months optimum medical therapy.We conducted the first study to examine the effects of optimisation to contemporary medical therapy on cardiac reverse remodelling, as demonstrated by cardiac magnetic resonance imaging (CMR).We hypothesised a proportion of patients would undergo beneficial remodelling and LVEF improvement above the threshold for complex device prescription after 6 months.

METHODS

HFrEF patients with symptomatic LVEF≤35% despite ACE inhibitor/beta blocker/mineralocorticoid receptor antagonist therapy, and qualified for sacubitril/valsartan switchover were recruited to this single centre prospective study.CMR was performed at baseline and at follow-up. Clinical, volumetric and outcome data were collected and compared.

RESULTS

Between June 2021 and August 2022, 49 patients were recruited. The majority (80%) were male, mean age 63±14 years. 35 (71%) had non-ischaemic cardiomyopathy. 2 (4%) patients died and 47 were followed up for a median of 7.4 months. There were no heart failure hospitalisations.Significant reductions were seen in median indexed left atrial volume: 54 mL/m (41-72) to 39 mL/m (30-60) (p<0.001); indexed left ventricular end-diastolic volume: 109 mL/m (74-125) to 76 mL/m (58-102) (p<0.001); indexed left ventricular end-systolic volume: 74mL/m (50-92) to 43 mL/m (27-58) (p<0.001) and mean indexed left ventricular mass: 72±13 g/m to 62±13 g/m (p<0.001).Median LVEF increased by 12 points from 31% to 43% (p<0.001). 29 (59%) patients improved to LVEF>35%. 13 (27%) patients improved to LVEF≥50%.Median N-terminal pro B type natriuretic peptide (NTproBNP) reduced from 883 ng/L (293-2043) to 429 ng/L (171-1421) (p<0.001).

CONCLUSIONS

Optimisation to contemporary HFrEF medical therapy results in beneficial cardiac reverse remodelling and significant improvements in LVEF and NTproBNP at 6 months as demonstrated by CMR. 59% of our cohort no longer met complex device indications. Guidelines suggest re-assessment of LVEF at 3 months, but our data suggests a longer period is required.

TRIAL REGISTRATION NUMBER

NCT05348226.

摘要

引言

射血分数降低的心力衰竭(HFrEF)指南推荐,如果在3个月的最佳药物治疗后左心室射血分数(LVEF)仍≤35%,则采用药物治疗和器械治疗的“四大支柱”。我们进行了第一项研究,以检验优化当代药物治疗对心脏逆向重构的影响,这通过心脏磁共振成像(CMR)得以证明。我们假设一部分患者在6个月后会发生有益的重构,且LVEF改善超过复杂器械处方的阈值。

方法

尽管接受了血管紧张素转换酶抑制剂/β受体阻滞剂/盐皮质激素受体拮抗剂治疗,但症状性LVEF≤35%且有资格转换为沙库巴曲缬沙坦的HFrEF患者被纳入这项单中心前瞻性研究。在基线和随访时进行CMR。收集并比较临床、容积和结局数据。

结果

在2021年6月至2022年8月期间,招募了49例患者。大多数(80%)为男性,平均年龄63±14岁。35例(71%)患有非缺血性心肌病。2例(4%)患者死亡,47例患者接受了中位7.4个月的随访。没有因心力衰竭住院的情况。观察到以下指标显著降低:中位标准化左心房容积从54 mL/m²(41 - 72)降至39 mL/m²(30 - 60)(p<0.001);标准化左心室舒张末期容积从109 mL/m²(74 - 125)降至76 mL/m²(58 - 102)(p<0.001);标准化左心室收缩末期容积从74mL/m²(50 - 92)降至43 mL/m²(27 - 58)(p<0.001);平均标准化左心室质量从72±13 g/m²降至62±13 g/m²(p<0.001)。中位LVEF从31%增加了12个百分点至43%(p<0.001)。29例(59%)患者的LVEF改善至>35%。13例(27%)患者的LVEF改善至≥50%。中位N末端B型利钠肽原(NTproBNP)从883 ng/L(293 - 2043)降至429 ng/L(171 - 1421)(p<0.001)。

结论

如CMR所示,优化当代HFrEF药物治疗可导致有益的心脏逆向重构,并在6个月时使LVEF和NTproBNP显著改善。我们队列中的59%不再符合复杂器械植入的指征。指南建议在3个月时重新评估LVEF,但我们的数据表明需要更长的时间。

试验注册号

NCT05348226。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/ea95de3fe030/openhrt-11-2-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/d533f38c0710/openhrt-11-2-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/471325c745a8/openhrt-11-2-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/ea95de3fe030/openhrt-11-2-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/d533f38c0710/openhrt-11-2-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/471325c745a8/openhrt-11-2-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dc96/11624772/ea95de3fe030/openhrt-11-2-g003.jpg

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