Chronic Chagas cardiomyopathy (CCC) has unique pathogenic and clinical features with worse prognosis than other causes of heart failure (HF), despite the fact that patients with CCC are often younger and have fewer comorbidities. Patients with CCC were not adequately represented in any of the landmark HF studies that support current treatment guidelines. PARACHUTE-HF (Prevention And Reduction of Adverse outcomes in Chagasic Heart failUre Trial Evaluation) is an active-controlled, randomized, phase IV trial designed to evaluate the effect of sacubitril/valsartan 200 mg twice daily vs enalapril 10 mg twice daily added to standard of care treatment for HF. The study aims to enroll approximately 900 patients with CCC and reduced ejection fraction at around 100 sites in Latin America. The primary outcome is a hierarchical composite of time from randomization to cardiovascular death, first HF hospitalization, or relative change from baseline to week 12 in NT-proBNP levels. PARACHUTE-HF will provide new data on the treatment of this high-risk population. (Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC [PARACHUTE-HF]; NCT04023227)

中文翻译：

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沙库巴曲/缬沙坦与依那普利治疗慢性恰加斯心肌病：PARACHUTE-HF 试验的基本原理和设计


慢性恰加斯心肌病 （CCC） 具有独特的致病和临床特征，预后比其他原因的心力衰竭 （HF） 更差，尽管 CCC 患者通常更年轻且合并症较少。CCC 患者在任何支持当前治疗指南的标志性 HF 研究中都没有得到充分代表。PARACHUTE-HF（预防和减少查加斯心力衰竭试验评估中的不良结局）是一项主动对照、随机、IV 期试验，旨在评估沙库巴曲/缬沙坦 200 毫克每天两次与依那普利 10 毫克每天两次添加到 HF 标准护理治疗中的效果。该研究旨在拉丁美洲约 100 个地点招募约 900 名射血分数降低的 CCC 患者。主要结果是从随机分组到心血管死亡、首次 HF 住院或 NT-proBNP 水平从基线到第 12 周的相对变化的时间的分层复合。PARACHUTE-HF 将提供有关治疗这一高危人群的新数据。（沙库巴曲/缬沙坦与依那普利相比对 CCC 患者发病率、死亡率和 NT-proBNP 变化的疗效和安全性 [降落伞-HF];NCT04023227）