Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ697 Compared With Enalapril in Pediatric Patients With Heart Failure
- Conditions
- Pediatric Heart Failure
- Registration Number
- JPRN-jRCT2080223850
- Lead Sponsor
- ovartis Pharma K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 360
*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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method