Sacubitril-Valsartan vs Enalapril in Heart Failure Due to Chagas Disease: Primary Results of ANSWER-HF Randomized Trial.

Sacubitril-valsartan has shown benefits in HFrEF of other etiologies, but less is known about its effects on CCC.

沙库巴曲-缬沙坦在其他病因的HFrEF中显示出益处，但关于其对CCC影响的了解较少。

The authors sought to compare the effects of sacubitril-valsartan vs enalapril on cardiac remodeling, functional outcomes, biomarkers, and safety in patients with CCC and HFrEF.

作者们试图比较沙库巴曲-缬沙坦与依那普利对伴有慢性收缩性心力衰竭（CCC）和射血分数降低的心力衰竭（HFrEF）患者的左心室重塑、功能结果、生物标志物和安全性的影响。

Methods

ANSWER-HF was a randomized, double-blind, controlled trial in Brazil.

ANSWER-HF是在巴西进行的一项随机、双盲、对照试验。

A total of 190 patients with CCC and HFrEF (left ventricular ejection fraction [LVEF] <40%, NYHA functional class II-IV) were randomized in a 1:1 ratio to sacubitril-valsartan or enalapril and followed for 6 months.

共有190名患有慢性收缩性心力衰竭（左心室射血分数[LVEF] <40%，纽约心脏病协会功能分级II-IV）的患者按1:1的比例随机分配到沙库巴曲-缬沙坦组或依那普利组，并随访6个月。

The primary endpoint was change in LVEF from baseline to 6 months.

主要终点是从基线到6个月时LVEF的变化。

The win ratio method analyzed the hierarchical secondary endpoint of cardiovascular death, heart failure hospitalization, N-terminal pro-B-type natriuretic (NT-proBNP) change, and LVEF change.

胜率方法分析了心血管死亡、心力衰竭住院、N末端前体B型利钠肽（NT-proBNP）变化和左心室射血分数（LVEF）变化的分层次要终点。

Results

Mean age was 61 years, 40% women, and 69% Black or mixed race.

平均年龄为61岁，女性占40%，黑人或混血占69%。

Baseline mean LVEF was 30.1%.

基线平均左心室射血分数（LVEF）为30.1%。

At 6 months, mean LVEF increased by 2.1% with sacubitril-valsartan and 1.2% with enalapril (between-group difference 0.9 percentage points; 95% CI: -0.9 to 2.6; P = 0.36).

6个月后，使用沙库巴曲-缬沙坦治疗的患者平均LVEF增加了2.1%，而使用依那普利治疗的患者增加了1.2%（两组间差异为0.9个百分点；95%置信区间：-0.9至2.6；P = 0.36）。

In hierarchical analysis, sacubitril-valsartan achieved more wins than enalapril (win ratio 1.80; 95% CI: 1.27-2.63).

在层次分析中，沙库巴曲-缬沙坦比依那普利取得了更多的胜利（胜利比率为1.80；95%置信区间：1.27-2.63）。

Median NT-proBNP was significantly lower with sacubitril-valsartan (geometric mean ratio 0.68; 95% CI: 0.57-0.81; P < 0.001).

沙库巴曲-缬沙坦的中位NT-proBNP显著较低（几何平均比率为0.68；95%置信区间：0.57-0.81；P < 0.001）。

No significant differences were observed in echocardiographic remodeling or 6-minute walk distance, and the occurrence of safety outcomes were comparable.

在超声心动图重塑或6分钟步行距离方面未观察到显著差异，且安全事件的发生率相当。

Conclusions

In patients with CCC and HFrEF, sacubitril-valsartan did not result in significant improvements in LVEF compared with enalapril after 6 months, but was associated with a greater reduction in NT-proBNP.

在患有慢性收缩性心力衰竭（CCC）和射血分数降低的心力衰竭（HFrEF）的患者中，与依那普利相比，沙库巴曲-缬沙坦在6个月后并未显著改善左心室射血分数（LVEF），但与更大的N末端前体脑钠肽（NT-proBNP）降低相关。

No safety concerns were associated with either the sacubitril-valsartan or enalapril group.

在沙库巴曲-缬沙坦组或依那普利组中，未发现与安全性相关的担忧。

These findings establish the feasibility and safety of conducting trials in this neglected disease, demonstrate biological activity of sacubitril-valsartan and enalapril in HFrEF due to CCC, and chart the path for larger, outcome-driven studies.

这些发现确立了在这一被忽视疾病中进行试验的可行性和安全性，证明了沙库巴曲-缬沙坦和依那普利在因慢性冠状动脉疾病引起的心力衰竭射血分数降低（HFrEF）中的生物学活性，并为更大规模、以结果为导向的研究指明了方向。

The ANSWER-HF represents an important step forward, beginning a new era of evidence generation for Chagas cardiomyopathy.

ANSWER-HF标志着重要进步，开启了恰加斯心肌病证据生成的新时代。

(Angiotensin Receptor-Neprilysin Inhibition in Chagas Cardiomyopathy With Reduced Ejection Fraction [ANSWER-HF]; NCT04853758).

(血管紧张素受体-肽酶抑制剂在射血分数降低的恰加斯心肌病中的应用[ANSWER-HF]; NCT04853758)。