Summary

Eligibility
for people ages 1 month to 17 years (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.

Official Title

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

Keywords

Pediatric Heart Failure Pediatric Heart failure, systemic left ventricle, reduced ejection fraction Heart Failure Enalapril Enalaprilat LCZ 696 LCZ696

Eligibility

For people ages 1 month to 17 years

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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

Locations

  • Novartis Investigative Site accepting new patients
    Los Angeles California 90095 United States
  • Novartis Investigative Site accepting new patients
    San Diego California 92123 United States
  • Novartis Investigative Site accepting new patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT02678312
Phase
Phase 2/3
Study Type
Interventional
Last Updated