EUCTR2015-003266-87-IT进行中（未招募）1 期
A multicenter, randomized, open label, parallel group study comparing predischargeand posT-discharge tReatment initiation with LCZ696 in heArtfailure patieNtS with reduced ejectIon-fracTion hospItalized for an acutedecOmpensation eveNt (ADHF) - TRANSITION study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,002
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients hospitalized due to acute decompensated HF episode (ADHF)
- •- Diagnosis of HF New York Heart Association class II-to-IV and reduced
- •ejection fraction
- •- 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
- •- Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 255
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1445
排除标准
- •- Symptomatic hypotension and/or a SBP < 110 mm Hg or SBP > 180
- •mm Hg prior to randomization
- •- End stage renal disease at ccreening; or estimated GFR < 30
- •mL/min/1.73 m2 as measured by (MDRD) formula at randomization.
- •- Serum potassium > 5.4 mmol/L at randomization.
- •- Current hospitalization where patient does not receive treatment for
- •decompensated HF.
- •- Known history of hereditary or idiopathic angioedema or angioedema
- •related to previous ACE inhibitor or ARB therapy
- •- Severe hepatic impairment, biliary cirrhosis and cholestasis
- •- Other protocol-defined exclusion criteria may apply.
研究者
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