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 FRACTIO

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 141 人开始时间: 2010年8月3日最近更新: 2023年9月4日

试验速览

暂无简介。

•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 and reduced ejection:
•LVEF ≤ 40% at visit 1 (any local measurement, made within the past 6 months using echocardiography, MUGA, CT scanning, MRI or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
•BNP ≥150 pg/ml (NT-proBNP ≥600 pg/ml) at Visit 1 OR BNP ≥100 pg/mL (NT-proBNP ≥ 400 pg/ml) and a hospitalization for HF within the last 12 months
•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 before Visit 1.
•5.Patients must be treated with a β-blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1.

•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 at Visit 1(scrreening) or < 95 mmHg at Visit 3 or at Visit 5 (randomization)
•8.Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula
•9.Serum potassium > 5.2 mmol/L at Visit 1 (screening) or > 5.4 mmol/L at Visit 3 or Visit 5 (randomization)
•Other protocol-defined exclusion criteria apply.

发起方

OVARTIS BIOSCIENSES PERU S.A.,