Last updated on May 2020

Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pediatric Heart Failure
  • Age: Between 1 - 17 Years
  • Gender: Male or Female

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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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