NCT02661217已完成4 期
A Multicenter, Randomized, Open Label, Parallel Group Study Comparing Pre-discharge and posT-discharge tReatment Initiation With LCZ696 in heArt Failure patieNtS With Reduced ejectIon-fracTion hospItalized for an Acute decOmpensation eveNt (ADHF)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,002
- 试验地点
- 1
- 主要终点
- Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
研究概览
简要总结
To explore two modalities of treatment initiation (Pre-discharge, and Post-discharge) with LCZ696 in HFrEF patients following stabilization after an ADHF episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized due to acute decompensated HF episode (ADHF) as primary diagnosis) and consistent Signs & Symptoms
- •Diagnosis of HF New York Heart Association class II-to-IV and reduced ejection fraction: Left ventricular ejection fraction ≤ 40% at Screening
- •Patients did not receive any IV vasodilators (except nitrates), and/or any IV inotropic therapy from the time of presentation for ADHF to Randomization
- •Stabilized (while in the hospital) for at least 24 hours leading to Randomization.
- •Meeting one of the following criteria:
- •Patients on any dose of ACEI or ARB at screening
- •ACEI/ARB naïve patients and patients not on ACEI or ARB for at least 4 weeks before screening.
排除标准
- •History of hypersensitivity to the sacubitril, valsartan, or any ARBs, NEP inhibitors or to any of the LCZ696 excipients.
- •Symptomatic hypotension and/or a SBP below 110 mm Hg or SBP above 180 mm Hg prior to randomization
- •End stage renal disease at Screening; or estimated GFR below 30 mL/min/1.73 m2 (as measured by MDRD formula at Randomization.
- •Serum potassium above 5.4 mmol/L at Randomization.
- •Known history of hereditary or idiopathic angioedema or angioedema related to previous ACE inhibitor or ARB therapy
- •Severe hepatic impairment, biliary cirrhosis and cholestasis
研究组 & 干预措施
Pre-discharge treatment initiation
Other
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
干预措施: LCZ696 (Drug)
Post-discharge treatment initiation
Other
Patients received first dose after discharge and up to 14 days thereafter.
干预措施: LCZ696 (Drug)
结局指标
主要结局
Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
时间窗: 10 weeks after Randomization
Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10
次要结局
- Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid(10 weeks after Randomization)
- Percentage of Patients Achieving and Maintaining Any Dose of LCZ696(10 weeks after Randomization)
- Percentage of Patients Permanently Discontinued From Treatment(10 weeks after Randomization AND 26 weeks after randomization)
研究者
研究点 (1)
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