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Association of Change in N-Terminal Pro–B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction
JAMA ( IF 63.1 ) Pub Date : 2019-09-17 , DOI: 10.1001/jama.2019.12821 James L Januzzi 1, 2 , Margaret F Prescott 3 , Javed Butler 4 , G Michael Felker 5 , Alan S Maisel 6 , Kevin McCague 3 , Alexander Camacho 1 , Ileana L Piña 7 , Ricardo A Rocha 3 , Amil M Shah 8 , Kristin M Williamson 3 , Scott D Solomon 8 ,
JAMA ( IF 63.1 ) Pub Date : 2019-09-17 , DOI: 10.1001/jama.2019.12821 James L Januzzi 1, 2 , Margaret F Prescott 3 , Javed Butler 4 , G Michael Felker 5 , Alan S Maisel 6 , Kevin McCague 3 , Alexander Camacho 1 , Ileana L Piña 7 , Ricardo A Rocha 3 , Amil M Shah 8 , Kristin M Williamson 3 , Scott D Solomon 8 ,
Affiliation
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Importance
In patients with heart failure and reduced ejection fraction (HFrEF), treatment with sacubitril-valsartan reduces N-terminal pro-b-type natriuretic peptide (NT-proBNP) concentrations. The effect of sacubitril-valsartan on cardiac remodeling is uncertain. Objective
To determine whether NT-proBNP changes in patients with HFrEF treated with sacubitril-valsartan correlate with changes in measures of cardiac volume and function. Design, Setting, and Participants
Prospective, 12-month, single-group, open-label study of patients with HFrEF enrolled in 78 outpatient sites in the United States. Sacubitril-valsartan was initiated and the dose adjusted. Enrollment commenced on October 25, 2016, and follow-up was completed on October 22, 2018. Exposures
NT-proBNP concentrations among patients treated with sacubitril-valsartan. Main Outcomes and Measures
The primary outcome was the correlation between changes in log2-NT-proBNP concentrations and left ventricular (LV) EF, LV end-diastolic volume index (LVEDVI), LV end-systolic volume index (LVESVI), left atrial volume index (LAVI), and ratio of early transmitral Doppler velocity/early diastolic annular velocity (E/e') at 12 months. Results
Among 794 patients (mean age, 65.1 years; 226 women [28.5%]; mean LVEF = 28.2%), 654 (82.4%) completed the study. The median NT-proBNP concentration at baseline was 816 pg/mL (interquartile range [IQR], 332-1822) and 455 pg/mL (IQR, 153-1090) at 12 months (difference, P < .001). At 12 months, the change in log2-NT-proBNP concentration was correlated with changes in LVEF (r = -0.381 [IQR, -0.448 to -0.310]; P < .001), LVEDVI (r = 0.320 [IQR, 0.246 to 0.391]; P < .001), LVESVI (r = 0.405 [IQR, 0.335 to 0.470]; P < .001), LAVI (r = 0.263 [IQR, 0.186 to 0.338]; P < .001), and E/e' (r = 0.269 [IQR, 0.182 to 0.353]; P < .001). At 12 months, LVEF increased from 28.2% to 37.8% (difference, 9.4% [95% CI, 8.8% to 9.9%]; P < .001), while LVEDVI decreased from 86.93 to 74.15 mL/m2 (difference, -12.25 mL/m2 [IQR, -12.92 to -11.58]; P < .001) and LVESVI decreased from 61.68 to 45.46 mL/m2 (difference, -15.29 mL/m2 [95% CI, -16.03 to -14.55]; P < .001). LAVI and E/e' ratio also decreased significantly. The most frequent adverse events were hypotension (17.6%), dizziness (16.8%), hyperkalemia (13.2%), and worsening kidney function (12.3%). Conclusions and Relevance
In this exploratory study of patients with HFrEF treated with sacubitril-valsartan, reduction in NT-proBNP concentration was weakly yet significantly correlated with improvements in markers of cardiac volume and function at 12 months. The observed reverse cardiac remodeling may provide a mechanistic explanation for the effects of sacubitril-valsartan in patients with HFrEF. Trial Registration
ClinicalTrials.gov Identifier: NCT02887183.
中文翻译：
射血分数降低的心力衰竭患者开始沙库巴曲缬沙坦治疗后 N 末端前-B 型利钠肽变化与心脏结构和功能的关联
重要性 在患有心力衰竭和射血分数降低 (HFrEF) 的患者中，使用沙库巴曲缬沙坦治疗可降低 N 末端前-b 型利钠肽 (NT-proBNP) 浓度。沙库巴曲缬沙坦对心脏重塑的影响尚不确定。目的 确定接受沙库巴曲缬沙坦治疗的 HFrEF 患者的 NT-proBNP 变化是否与心容量和功能测量值的变化相关。设计、设置和参与者前瞻性、为期 12 个月、单组、开放标签的 HFrEF 患者研究，在美国 78 个门诊点登记。开始使用沙库巴曲缬沙坦并调整剂量。入组于 2016 年 10 月 25 日开始，随访于 2018 年 10 月 22 日完成。在接受沙库巴曲缬沙坦治疗的患者中暴露 NT-proBNP 浓度。主要结果和测量 主要结果是 log2-NT-proBNP 浓度变化与左心室 (LV) EF、左室舒张末期容积指数 (LVEDVI)、左室收缩末期容积指数 (LVESVI)、左心房容积之间的相关性指数 (LAVI)，以及 12 个月时的早期二尖瓣多普勒速度/舒张早期环速度 (E/e') 的比率。结果 在 794 名患者（平均年龄 65.1 岁；226 名女性 [28.5%]；平均 LVEF = 28.2%）中，654 名（82.4%）完成了研究。基线时 NT-proBNP 浓度中位数为 816 pg/mL（四分位距 [IQR]，332-1822）和 12 个月时 455 pg/mL（IQR，153-1090）（差异，P < .001）。在 12 个月时，log2-NT-proBNP 浓度的变化与 LVEF (r = -0.381 [IQR, -0.448 to -0.310]; P < .001), LVEDVI (r = 0.320 [IQR, 0.246 to 0.391]；P < .001)，LVESVI (r = 0.405 [IQR, 0.335 to 0.470]; P < .001), LAVI (r = 0.263 [IQR, 0.186 to 0.338]; P < .001), and E/e' (r = 0.269 [IQR, 0.182 至 0.353]；P < .001)。12 个月时，LVEF 从 28.2% 增加到 37.8%（差异，9.4% [95% CI，8.8% 到 9.9%]；P < .001），而 LVEDVI 从 86.93 下降到 74.15 mL/m2（差异，-12.25 mL/m2 [IQR，-12.92 至 -11.58]；P < .001）和 LVESVI 从 61.68 降至 45.46 mL/m2（差异，-15.29 mL/m2 [95% CI，-16.03 至 -14.55]；P < .001)。LAVI 和 E/e' 比率也显着下降。最常见的不良事件是低血压（17.6%）、头晕（16.8%）、高钾血症（13.2%）和肾功能恶化（12.3%）。结论和相关性 在这项对接受沙库巴曲缬沙坦治疗的 HFrEF 患者的探索性研究中，NT-proBNP 浓度的降低与 12 个月时心脏容量和功能标志物的改善呈微弱但显着相关。观察到的反向心脏重塑可能为沙库巴曲缬沙坦对 HFrEF 患者的作用提供了机制解释。试验注册 ClinicalTrials.gov 标识符：NCT02887183。
更新日期：2019-09-17
中文翻译：
射血分数降低的心力衰竭患者开始沙库巴曲缬沙坦治疗后 N 末端前-B 型利钠肽变化与心脏结构和功能的关联
重要性 在患有心力衰竭和射血分数降低 (HFrEF) 的患者中，使用沙库巴曲缬沙坦治疗可降低 N 末端前-b 型利钠肽 (NT-proBNP) 浓度。沙库巴曲缬沙坦对心脏重塑的影响尚不确定。目的 确定接受沙库巴曲缬沙坦治疗的 HFrEF 患者的 NT-proBNP 变化是否与心容量和功能测量值的变化相关。设计、设置和参与者前瞻性、为期 12 个月、单组、开放标签的 HFrEF 患者研究，在美国 78 个门诊点登记。开始使用沙库巴曲缬沙坦并调整剂量。入组于 2016 年 10 月 25 日开始，随访于 2018 年 10 月 22 日完成。在接受沙库巴曲缬沙坦治疗的患者中暴露 NT-proBNP 浓度。主要结果和测量 主要结果是 log2-NT-proBNP 浓度变化与左心室 (LV) EF、左室舒张末期容积指数 (LVEDVI)、左室收缩末期容积指数 (LVESVI)、左心房容积之间的相关性指数 (LAVI)，以及 12 个月时的早期二尖瓣多普勒速度/舒张早期环速度 (E/e') 的比率。结果 在 794 名患者（平均年龄 65.1 岁；226 名女性 [28.5%]；平均 LVEF = 28.2%）中，654 名（82.4%）完成了研究。基线时 NT-proBNP 浓度中位数为 816 pg/mL（四分位距 [IQR]，332-1822）和 12 个月时 455 pg/mL（IQR，153-1090）（差异，P < .001）。在 12 个月时，log2-NT-proBNP 浓度的变化与 LVEF (r = -0.381 [IQR, -0.448 to -0.310]; P < .001), LVEDVI (r = 0.320 [IQR, 0.246 to 0.391]；P < .001)，LVESVI (r = 0.405 [IQR, 0.335 to 0.470]; P < .001), LAVI (r = 0.263 [IQR, 0.186 to 0.338]; P < .001), and E/e' (r = 0.269 [IQR, 0.182 至 0.353]；P < .001)。12 个月时，LVEF 从 28.2% 增加到 37.8%（差异，9.4% [95% CI，8.8% 到 9.9%]；P < .001），而 LVEDVI 从 86.93 下降到 74.15 mL/m2（差异，-12.25 mL/m2 [IQR，-12.92 至 -11.58]；P < .001）和 LVESVI 从 61.68 降至 45.46 mL/m2（差异，-15.29 mL/m2 [95% CI，-16.03 至 -14.55]；P < .001)。LAVI 和 E/e' 比率也显着下降。最常见的不良事件是低血压（17.6%）、头晕（16.8%）、高钾血症（13.2%）和肾功能恶化（12.3%）。结论和相关性 在这项对接受沙库巴曲缬沙坦治疗的 HFrEF 患者的探索性研究中，NT-proBNP 浓度的降低与 12 个月时心脏容量和功能标志物的改善呈微弱但显着相关。观察到的反向心脏重塑可能为沙库巴曲缬沙坦对 HFrEF 患者的作用提供了机制解释。试验注册 ClinicalTrials.gov 标识符：NCT02887183。
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