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 Services Inc.0 个研究点目标入组 10 人开始时间: 2022年12月9日最近更新: 2024年8月19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

发起方

ovartis Pharma Services Inc.