Key Laboratory of Cardiovascular Remodeling and Function Research, Chinese Ministry of Education, Chinese National Health Commission and Chinese Academy of Medical Sciences, State and Shandong Province Joint Key Laboratory of Translational Cardiovascular Medicine, Department of Cardiology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, 250012, Shandong, China.
ESC Heart Fail. 2023 Jun;10(3):1961-1971. doi: 10.1002/ehf2.14367. Epub 2023 Mar 29.
The study aims to explore the real-world titration patterns of sacubitril/valsartan in a chronic heart failure (HF) follow-up management system and the effect on the recovery of ventricular remodelling and cardiac function in China.
This is a single-centre, observational study of 153 adult outpatients with HF and reduced ejection fraction who were managed in the chronic HF follow-up management system and prescribed with sacubitril/valsartan from August 2017 to August 2021 in China. All patients tried to titrated sacubitril/valsartan to the tolerant dose during follow-up. The primary outcome was the proportion of patients who reached and maintained the target dose of sacubitril/valsartan. The main secondary outcomes were the changes in left atrium diameter, left ventricular end-diastolic diameter (LVEDD), and left ventricular ejection fraction (LVEF) from baseline to 12 months. Among the patients, 69.3% were male, with a median age of 49 years. The baseline systolic blood pressure (SBP) was 117.6 ± 18.3 mmHg before starting the treatment of sacubitril/valsartan. Benefiting from the management system, 117 (76.5%) patients achieved the target dose of sacubitril/valsartan, and the median time to reach the target dose was 3 (IQR 1-5) months. Advanced age and lower SBP may be predictors of failure to reach the target dose. Compared with baseline, standard treatment resulted in a pronounced improvement in left ventricular geometry and cardiac function. The patients showed a significant increase in LVEF [28 (IQR 21-34) % vs. 42 (IQR 37.0-54.3) %, P < 0.001], with a great reduction in left atrium diameter [45 (IQR 40.3-51.0) mm vs. 41 (IQR 37.0-45.3) mm, P < 0.001] and LVEDD [65 (IQR 60.0-70.3) mm vs. 55 (IQR 52-62) mm, P < 0.001] during 12 month follow-up. Of patients, 36.5% had a LVEF ≥50%, 54.1% had LVEF >40%, and 81.1% experienced an increase in LVEF of ≥10%. After 12 month follow-up, the proportion of patients with New York Heart Association classification I or II increased from 41.8% to 96.4%. Additionally, there was a significant improvement in N-terminal pro-B-type natriuretic peptide (P < 0.001). At Month 12, 50% of patients achieved the target dose of beta-blockers. No serious adverse events caused by sacubitril/valsartan were observed during the follow-up.
Optimising HF follow-up management was essential and effective in a real-world clinical setting; the majority could reach the target dose of sacubitril/valsartan within the management system and achieve a remarkable improvement in cardiac function and ventricular remodelling.
本研究旨在探讨沙库巴曲缬沙坦在慢性心力衰竭（HF）随访管理系统中的真实世界滴定模式及其对中国心室重构和心功能恢复的影响。
这是一项在中国进行的单中心、观察性研究，共纳入 153 例在慢性 HF 随访管理系统中接受治疗且接受沙库巴曲缬沙坦治疗的射血分数降低的成年门诊患者。所有患者在随访期间均尝试滴定沙库巴曲缬沙坦至耐受剂量。主要结局为达到并维持沙库巴曲缬沙坦目标剂量的患者比例。主要次要结局为从基线到 12 个月时左心房直径、左心室舒张末期直径（LVEDD）和左心室射血分数（LVEF）的变化。患者中，69.3%为男性，中位年龄为 49 岁。开始沙库巴曲缬沙坦治疗前，收缩压（SBP）基线为 117.6±18.3mmHg。得益于管理系统，117（76.5%）例患者达到沙库巴曲缬沙坦的目标剂量，达到目标剂量的中位时间为 3（IQR 1-5）个月。高龄和较低的 SBP 可能是未能达到目标剂量的预测因素。与基线相比，标准治疗显著改善了左心室几何形状和心功能。患者的 LVEF[28（IQR 21-34）% vs. 42（IQR 37.0-54.3）%，P<0.001]显著增加，左心房直径[45（IQR 40.3-51.0）mm vs. 41（IQR 37.0-45.3）mm，P<0.001]和 LVEDD[65（IQR 60.0-70.3）mm vs. 55（IQR 52-62）mm，P<0.001]在 12 个月随访期间明显降低。在患者中，36.5%的患者 LVEF≥50%，54.1%的患者 LVEF>40%，81.1%的患者 LVEF增加≥10%。在 12 个月随访后，纽约心脏协会（NYHA）心功能分级 I 或 II 级的患者比例从 41.8%增加到 96.4%。此外，N 端脑利钠肽前体（P<0.001）显著改善。在第 12 个月时，50%的患者达到了β受体阻滞剂的目标剂量。在随访期间，未观察到沙库巴曲缬沙坦引起的严重不良事件。
优化 HF 随访管理在真实世界临床环境中是必要且有效的；大多数患者可以在管理系统中达到沙库巴曲缬沙坦的目标剂量，并在心功能和心室重构方面取得显著改善。
