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与依那普利相比，沙库巴曲/缬沙坦对 CCC 患者发病率、死亡率和 NT-proBNP 变化的疗效和安全性 (PARACHUTE-HF)

2026年4月17日 更新者：Novartis Pharmaceuticals

一项多中心、前瞻性、随机、开放标签、盲终点、4 期研究，以评估沙库巴曲/缬沙坦与依那普利相比对慢性南美锥虫心肌病患者发病率、死亡率和 NT-proBNP 变化的疗效和安全性

本研究的目的是评估 sacubitril/valsartan 200 mg BID 与依那普利 10 mg BID 相比，除了常规心力衰竭 (HF) 治疗外，在改善心血管 (CV) 事件（即 CV 死亡或首次 HF 住院的发生）并导致由 CCC 引起的射血分数降低 (HFrEF) 的 HF 参与者的脑利钠肽末端激素原（NT-proBNP，从基线开始第 12 周）大幅减少。

研究概览

地位

完全的

条件

干预/治疗

详细说明

This was a multinational, multicenter, parallel-group, prospective, randomized, open-label, with blinded-endpoint adjudication, active-controlled study. The target projected sample size was approximately 900 participants (450 in each arm). It was estimated that approximately 1800 participants would be screened at sites in Latin America, including Argentina, Brazil, Colombia, and Mexico.

Participants who met the eligibility requirements were randomly assigned in a 1:1 ratio to receive sacubitril/valsartan (target dose of 200 mg twice daily) or enalapril (target dose of 10 mg twice daily), in addition to their usual therapy, stratified by country, using a central, concealed, web-based, automated randomization system. Both groups entered a titration period of 3 to 6 weeks, aiming to achieve the target dose of sacubitril/valsartan 200 mg twice daily or enalapril 10 mg twice daily. The study follow-up succeeded the titration period and was to last until a total number of 302 events was reached and all randomized participants had a minimum follow-up of 12 weeks.

研究类型

介入性

注册 (实际的)

922

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 哥伦比亚
      • Bogota DC、哥伦比亚、110111
        • Novartis Investigative Site
      • Florida Blanca、哥伦比亚、681001
        • Novartis Investigative Site
      • Floridablanca、哥伦比亚、681004
        • Novartis Investigative Site
    • Cundinamarca
      • Bogota、Cundinamarca、哥伦比亚、110121
        • Novartis Investigative Site
    • Magdalena Department
      • Santa Marta、Magdalena Department、哥伦比亚、30360
        • Novartis Investigative Site
    • Santander Department
      • San Gil、Santander Department、哥伦比亚、684031
        • Novartis Investigative Site
  • 墨西哥
      • Ciudad de、墨西哥、14080
        • Novartis Investigative Site
      • Oaxaca City、墨西哥、68000
        • Novartis Investigative Site
      • Xalapa、墨西哥、91193
        • Novartis Investigative Site
    • Yucatán
      • Mérida、Yucatán、墨西哥、97000
        • Novartis Investigative Site
  • 巴西
      • São Paulo、巴西、05403-000
        • Novartis Investigative Site
      • São Paulo、巴西、15015-210
        • Novartis Investigative Site
    • Ceará
      • Fortaleza、Ceará、巴西、60430 370
        • Novartis Investigative Site
      • Fortaleza、Ceará、巴西、60125-025
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、41253-190
        • Novartis Investigative Site
      • Salvador、Estado de Bahia、巴西、40050-410
        • Novartis Investigative Site
      • Salvador、Estado de Bahia、巴西、40110060
        • Novartis Investigative Site
      • Salvador、Estado de Bahia、巴西、40323-010
        • Novartis Investigative Site
    • Federal District
      • Brasila、Federal District、巴西、70673623
        • Novartis Investigative Site
      • Brasília、Federal District、巴西、70390-700
        • Novartis Investigative Site
      • Brasília、Federal District、巴西、70673-416
        • Novartis Investigative Site
    • Goiás
      • Goiânia、Goiás、巴西、74605-020
        • Novartis Investigative Site
      • Goiânia、Goiás、巴西、74223-060
        • Novartis Investigative Site
      • Goiânia、Goiás、巴西、74223-130
        • Novartis Investigative Site
    • Maranhão
      • São Luís、Maranhão、巴西、65020-070
        • Novartis Investigative Site
    • Minas Gerais
      • Belo Horizonte、Minas Gerais、巴西、30150-270
        • Novartis Investigative Site
      • Belo Horizonte、Minas Gerais、巴西、30130-100
        • Novartis Investigative Site
      • Belo Horizonte、Minas Gerais、巴西、30140 062
        • Novartis Investigative Site
      • Montes Claros、Minas Gerais、巴西、39401-001
        • Novartis Investigative Site
      • Passos、Minas Gerais、巴西、37904-020
        • Novartis Investigative Site
      • Uberaba、Minas Gerais、巴西、38025-440
        • Novartis Investigative Site
      • Uberlândia、Minas Gerais、巴西、38400 500
        • Novartis Investigative Site
      • Uberlândia、Minas Gerais、巴西、38400-328
        • Novartis Investigative Site
    • Paraná
      • Londrina、Paraná、巴西、86038-440
        • Novartis Investigative Site
    • Pará
      • Belém、Pará、巴西、66087-660
        • Novartis Investigative Site
    • Pernambuco
      • Recife、Pernambuco、巴西、50100-060
        • Novartis Investigative Site
    • Piauí
      • Teresina、Piauí、巴西、64001-380
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Ijuí、Rio Grande do Sul、巴西、98700-000
        • Novartis Investigative Site
    • Rio de Janeiro
      • Rio de Janeiro、Rio de Janeiro、巴西、20551-030
        • Novartis Investigative Site
      • Rio de Janeiro、Rio de Janeiro、巴西、22240-006
        • Novartis Investigative Site
    • São Paulo
      • Botucatu、São Paulo、巴西、3880-1001
        • Novartis Investigative Site
      • Bragança Paulista、São Paulo、巴西、13183-091
        • Novartis Investigative Site
      • Campinas、São Paulo、巴西、13060 080
        • Novartis Investigative Site
      • Campinas、São Paulo、巴西、13020-431
        • Novartis Investigative Site
      • Campinas、São Paulo、巴西、13060-904
        • Novartis Investigative Site
      • Indaiatuba、São Paulo、巴西、13330-570
        • Novartis Investigative Site
      • Marília、São Paulo、巴西、17515-000
        • Novartis Investigative Site
      • Ribeirão Preto、São Paulo、巴西、14048-900
        • Novartis Investigative Site
      • Ribeirão Preto、São Paulo、巴西、14010-190
        • Novartis Investigative Site
      • Santo André、São Paulo、巴西、09080-001
        • Novartis Investigative Site
      • Sao Jose Rio Preto、São Paulo、巴西、15090-000
        • Novartis Investigative Site
      • São Paulo、São Paulo、巴西、05403-000
        • Novartis Investigative Site
      • São Paulo、São Paulo、巴西、04012 909
        • Novartis Investigative Site
      • Tatuí、São Paulo、巴西、18270-170
        • Novartis Investigative Site
      • Votuporanga、São Paulo、巴西、15500 003
        • Novartis Investigative Site
  • 阿根廷
      • Buenos Aires、阿根廷、C1155 AHD
        • Novartis Investigative Site
      • Corrientes、阿根廷、W3400CDS
        • Novartis Investigative Site
      • Córdoba、阿根廷、5000
        • Novartis Investigative Site
      • Córdoba、阿根廷、X5003DCE
        • Novartis Investigative Site
      • Córdoba、阿根廷、X5004BAL
        • Novartis Investigative Site
      • Córdoba、阿根廷、X5006CBI
        • Novartis Investigative Site
      • Formosa、阿根廷、P3600
        • Novartis Investigative Site
      • Formosa、阿根廷、P3634XAR
        • Novartis Investigative Site
      • Mendoza、阿根廷、M5500CHC
        • Novartis Investigative Site
      • Santa Fe、阿根廷、S3000FWO
        • Novartis Investigative Site
      • Santa Fe、阿根廷、S3000EOZ
        • Novartis Investigative Site
      • Santiago del Estero、阿根廷、G4200AQK
        • Novartis Investigative Site
    • Buenos Aires
      • CABA、Buenos Aires、阿根廷、C1221ADC
        • Novartis Investigative Site
      • CABA、Buenos Aires、阿根廷、C1425BEI
        • Novartis Investigative Site
      • Ramos Mejía、Buenos Aires、阿根廷、B1704ETD
        • Novartis Investigative Site
      • San Martín、Buenos Aires、阿根廷、1604
        • Novartis Investigative Site
      • Temperley、Buenos Aires、阿根廷、1834
        • Novartis Investigative Site
    • Córdoba Province
      • Villa María、Córdoba Province、阿根廷、X5900JKA
        • Novartis Investigative Site
    • Salta Province
      • Salta、Salta Province、阿根廷、A4406BPF
        • Novartis Investigative Site
    • San Miguel de Tucuman
      • San Miguel de Tucumán、San Miguel de Tucuman、阿根廷、T4000ICL
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、2000
        • Novartis Investigative Site
      • Rosario、Santa Fe Province、阿根廷、S2000DIF
        • Novartis Investigative Site
    • Tucumán Province
      • San Miguel Tucuman、Tucumán Province、阿根廷、T4000IFL
        • Novartis Investigative Site
      • San Miguel Tucuman、Tucumán Province、阿根廷、T4000JCU
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

关键纳入标准：

  • ≥ 18 岁的男性或女性

  • NYHA II-IV 级 HFrEF 的诊断依据：

    1. 使用超声心动图、多门控采集扫描 (MUGA)、计算机断层扫描 (CT) 扫描、磁共振成像 (MRI) 或心室血管造影术进行的任何局部测量在第 1 次就诊前 12 个月内 LVEF ≤ 40%，前提是没有上述后续测量40% 和
    2. 第 1 次就诊时 NT-proBNP ≥ 600 pg/mL（或 BNP ≥ 150 pg/mL）或
    3. 第 1 次就诊时 NT-proBNP ≥ 400 pg/mL（或 BNP ≥ 100 pg/mL）并且在过去 12 个月内因 HF 住院
  • 南美锥虫病的诊断通过至少两种基于不同原理或使用不同抗原制剂的不同抗克氏锥虫血清学试验得到证实，例如：酶联免疫吸附试验 [ELISA]、间接免疫荧光 [IFI]、间接血凝试验 [IHA] , 蛋白质印迹 (WB), 化学发光免疫分析 (CLIA)。 如果没有记录的病史，则可以在筛选期间进行测试

关键排除标准：

  • 有疑似或证实的血管性水肿病史或不能耐受 ACEI、ARB 或 ARNI（例如，由于咳嗽、低血压、肾功能不全、高钾血症）的患者
  • 在过去 3 个月内使用过沙库巴曲/缬沙坦

  • 需要持续静脉正性肌力治疗或有 HF 高级支持干预指征的患者：

    1. 已经在心脏移植名单上
    2. 具有左心室辅助装置或心脏再同步化治疗 (CRT) 的当前指征
  • 全身收缩压低于 95 mmHg 或症状性低血压
  • 血清钾 > 5.2 mmol/L
  • 估计肾小球滤过率 (eGFR) < 30 mL/min/1.73 m2 体表面积
  • 慢性恰加斯病的严重胃肠道形式（表现出巨食管和/或重要的巨结肠，例如：口服摄入量或手术适应症受损）。
  • 限制适当患者参与的临床状况或全身性疾病
  • 孕妇或哺乳期妇女或有生育能力的妇女，除非她们使用高效的避孕方法

  • 存在其他心脏病：

    1. 既往心脏手术
    2. 心力衰竭，根据研究者的判断，存在可能的替代主要病因，例如冠状动脉疾病、瓣膜病、先天性心脏病或其他原因。
    3. 未经治疗的心律失常或严重的传导疾病，例如心动过缓、伴有快速心室反应的房颤、二度或三度房室传导阻滞等。
    4. 原发性未矫正的瓣膜病变，如中度至重度主动脉瓣狭窄、二尖瓣狭窄和原发性二尖瓣反流
    5. 计划器官移植（或在移植上市）、计划心脏或其他大手术（包括心室辅助装置植入）
  • 过去 5 年内任何器官系统恶性肿瘤的病史。
  • 当前确诊的 COVID19 感染
  • 既往 COVID19 感染且疑似由 COVID19 引起的持续症状负担（持续症状可能包括但不限于从 COVID19 感染时起持续咳嗽、呼吸困难、肌肉/关节疼痛和胃肠道症状）

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Sacubitril/valsartan
Participants received 3 to 6 weeks of titrated dosing with sacubitril/valsartan to achieve the target dose of 200 mg twice daily.
药品：Sacubitril/valsartan
Participants randomized to sacubitril/valsartan who were previously treated with angiotensin-converting enzyme inhibitors (ACEIs) had a 36-hour washout prior to receiving oral treatment with 50, 100, or 200 mg, film-coated tablets.
其他名称：
  • LCZ696;快餐；维马达
有源比较器：Enalapril
Participants received 3 to 6 weeks of titrated dosing with enalapril to achieve the target dose of 10 mg twice daily.
药品：Enalapril
Oral treatment with 5 or 10 mg tablets.
其他名称：
  • 雷尼泰克

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Hierarchical Composite Endpoint Composed of Time to Cardiovascular (CV) Death, Time to First Heart Failure (HF) Hospitalization, and Relative Change in NT-proBNP From Baseline to Week 12
大体时间：Total follow-up time up to approximately 36 months
The primary efficacy endpoint was analyzed using the win ratio approach comparing every participant in the sacubitril/valsartan arm to every participant in the enalapril arm to determine a winner. A winner in the pair-wise comparison had a delayed time to the occurrence of CV death; if time to the occurrence of CV death was censored, a winner had a delayed time to the occurrence of first HF hospitalization event; if the times to both CV events were censored, a winner had a more favorable (less increase or more decrease) change in NT-proBNP between Baseline and Week 12. The estimated win ratio was defined as the total number of winners in the sacubitril/valsartan arm divided by the total number of winners in the enalapril arm. A win ratio >1 represents a favorable outcome for the study drug being assessed.
Total follow-up time up to approximately 36 months
Percentage of Participants Who Died From Cardiovascular Causes
大体时间：Total follow up time up to approximately 36 months
Total follow up time up to approximately 36 months
Percentage of Participants With First Hospitalization for Worsening Heart Failure
大体时间：Total follow up time up to approximately 36 months
Total follow up time up to approximately 36 months
Change From Baseline to Week 12 in NT-proBNP Levels
大体时间：Baseline to Week 12
Geometric mean factor change was derived from a linear regression model of log(NT-proBNP), adjusted for country and baseline value.
Baseline to Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With First Hospitalization Due to Heart Failure or Death From Cardiovascular Causes
大体时间：From the date of randomization to the first occurrence (total follow up time up to approximately 36 months)
From the date of randomization to the first occurrence (total follow up time up to approximately 36 months)
Percentage of Participants Who Died From Any Cause
大体时间：From date of randomization until the date of death from any cause assessed up to the end of the study, up to approximately 36 months
From date of randomization until the date of death from any cause assessed up to the end of the study, up to approximately 36 months
Number of Participants Who Had Sudden Death or Resuscitated Sudden Cardiac Arrest
大体时间：From date of randomization until the date of the sudden death or resuscitated sudden cardiac arrest assessed up to the end of the study, up to approximately 36 months
From date of randomization until the date of the sudden death or resuscitated sudden cardiac arrest assessed up to the end of the study, up to approximately 36 months
Number of Participants Who Had Visits to an Emergency Room Due to Heart Failure (HF) Where Intravenous Therapy Was Required
大体时间：From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
Number of Days Alive and Out of the Hospital
大体时间：From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
The duration of hospital-free survival within 1 year from randomization was summarized.
From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
Number of Hospitalizations Due to Heart Failure (HF) or Death Due to Cardiovascular (CV) Causes (Recurrent Events)
大体时间：From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
From the date of randomization up to end of study. Total follow up time up to approximately 36 months.

其他结果措施

结果测量
措施说明
大体时间
Number of Ventricular Fibrillation or Sustained Ventricular Tachycardia
大体时间：From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
The number of ventricular fibrillation or sustained ventricular tachycardia needing specific pharmacological, electrical or other treatment was determined.
From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
Number of Anti-tachycardia Pacing or Shock Therapies
大体时间：From the date of randomization up to end of study. Total follow up time up to approximately 36 months.
From the date of randomization up to end of study. Total follow up time up to approximately 36 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Novartis Pharmaceuticals

调查人员

  • 研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年12月10日

初级完成 (实际的)

2025年3月16日

研究完成 (实际的)

2025年3月31日

研究注册日期

首次提交

2019年7月10日

首先提交符合 QC 标准的

2019年7月16日

首次发布 (实际的)

2019年7月17日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年4月17日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CLCZ696B3302

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

诺华致力于与合格的外部研究人员共享患者水平数据的访问权限，并支持符合条件的研究的临床文件。 这些请求由独立审查小组根据科学价值审查和批准。 所提供的所有数据均已匿名处理，以根据适用的法律法规尊重参与试验的患者的隐私。

此试验数据的可用性是根据 www.clinicalstudydatarequest.com 上描述的标准和过程。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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