Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction

ovartis Pharma K.K.0 个研究点目标入组 360 人开始时间: 2018年3月30日最近更新: 2023年10月17日

研究概览

暂无简介。

•*Chronic heart failure resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
•*NYHA classification II-IV (older children: 6 to <18 years old) or Ross CHF classification II-IV (younger children: < 6 years old)
•*Systemic left ventricular ejection fraction =< 40% or fractional shortening =<20%
•*For Part 1 study: Patients must be treated with an ACEI or ARB prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg.
•*Biventricular physiology with systemic left ventricle

•*Patient with single ventricle or systemic right ventricle
•*Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device)
•*Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy
•*Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2
•*Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction
•*Patients with restrictive or hypertrophic cardiomyopathy
•*Active myocarditis
•*Renal vascular hypertension (including renal artery stenosis)
•*Moderate-to severe obstructive pulmonary disease
•*Serum potassium > 5.3 mmol/L
•*History of angioedema
•*Allergy or hypersensitivity to ACEI / ARB
•Other protocol-defined inclusion/exclusion criteria may apply.

发起方

ovartis Pharma K.K.