A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril on morbidity and mortality in patients with chronic heart failure and reduced ejection fraction - PARADIGM-HF

ovartis Pharma Services AG0 个研究点目标入组 7,980 人开始时间: 2009年11月4日最近更新: 2014年7月14日

适应症

试验速览

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•1. Patients must give written informed consent before any assessment is performed.
•2. Outpatients = 18 years of age, male or female.
•3. Patients with a diagnosis of CHF NYHA class, II-IV, reduced ejection fraction (EF = 35%) and elevated BNP.
•4. Patients must be on an ACEI or an ARB at a stable dose of at least enalapril 10 mg/d or equivalent for at least 4 weeks
•5. Patients must be treated with a ß-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks
•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 4200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4200

•1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
•2. History of hypersensitivity or allergy to any of the study drugs, drugs of similar chemical classes, ACEIs, ARBs, or NEP inhibitors as well as known or suspected contraindications to the study drugs
•3. Previous history of intolerance to recommended target doses of ACEIs or ARBs
•4. Known history of angioedema
•5. Requirement of treatment with both ACEIs and ARBs
•6. Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
•7. Symptomatic hypotension and/or a SBP < 100 mmHg
•8. Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula

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