Study to determine safety, tolerability, pharmacokinetics and pharmacodynamicsof LCZ696 in children aged 1 month to less than 18 years with heart failure due tosystemic left ventricle systolic dysfunctio
- Conditions
- Health Condition 1: null- Pediatric Heart FailureHealth Condition 2: I502- Systolic (congestive) heart failure
- Registration Number
- CTRI/2018/09/015752
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Written informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some patients depending upon their age and local requirements
2.Male or female, inpatient or outpatient, 1 month to < 18 years of age
3.Chronic heart failure resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed)
4.NYHA classification II-IV (older children: 6 to <18 years old) or Ross CHF classification II-IV (younger children: < 6 years old) any time prior to screening
5.Systemic left ventricular ejection fraction (EF) <= 40% or fractional shortening <=20% (assessed by most recent echocardiography, MRI, MUGA or left ventricular angiogram within 1 month from screening)
6.Biventricular physiology with systemic left ventricle
1.Patient with single ventricle or systemic right ventricle
2.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)
3.Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy
4.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
5.Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction
6.Patients with restrictive or hypertrophic cardiomyopathy
7.Active myocarditis
8.Renal vascular hypertension (including renal artery stenosis)
9.Moderate-to severe obstructive pulmonary disease
10.Serum potassium > 5.3 mmol/L
11.History of angioedema
12.Allergy or hypersensitivity to ACEI / ARB
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to determine whether LCZ696 is superior to enalapril for the <br/ ><br>treatment of HF as assessed using a global rank endpoint in pediatric HF patientsTimepoint: Up to 52 weeks
- Secondary Outcome Measures
Name Time Method -To determine whether LCZ696 is superior to enalapril in delaying time to first occurrence of the composite of either Category 1 or 2 events (e.g. death, worsening HF) <br/ ><br>-To determine whether LCZ696 is superior to enalapril for improving NYHA/Ross functional class <br/ ><br>Timepoint: Baseline to 52 weeks;-To determine whether LCZ696 is superior to enalapril for improving the Patient Global <br/ ><br>Impression of Severity (PGIS) score <br/ ><br>-To characterize the population PK of LCZ696 exposure in pediatric patients with HF <br/ ><br>-To assess the safety and tolerability of LCZ696 compared to enalapril in pediatric patients <br/ ><br>with HF <br/ ><br>Timepoint: Baseline to 52 weeks;Time to first occurrence of Category 1 or Category 2 eventTimepoint: Up to 52 weeks