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LCZ696 or Enalapril for Children With Heart Failure - Clinical Trial

What is the Purpose of this Study?

We are doing this study is to find out if LCZ696 will be better than Enalapril in children with heart failure.   

What is the Condition Being Studied?

Heart Failure in Children

Who Can Participate in the Study?

Children who:
 - Are 1 month to 17 years old
- Have heart failure due to systemic left ventricle systolic dysfunction (the left side of your heart isn't working as well as it should)

Age Group
Children

What is Involved?

This study is divided into two parts.

If you decide to be in this study:

During Part 1, you will:
-- Take LCZ696 by mouth
-- Be divided into three groups depending on age (6-17 years, 12 months to less than 6 years, and 1 month to less than 1 year old) that will determine what dose of the study drug your child gets

After you finish Part 1, you will be asked if you are interested in joining Part 2.  
In Part 2, you will:
-Be randomly assigned, like a flip of a coin, into one of two groups:
-- Group 1: Will take LCZ696 by mouth
-- Group 2: Will take Enalapril by mouth

Study Details

Full Title
Multicenter, open-label, study to evaluate safety, tolerability and PD/PK of LCZ696 followed by a 52-week randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of LCZ696 compared to enalapril in pediatric patients
Principal Investigator
Electrophysiologist
Protocol Number
IRB:PRO00071235
NCT:NCT02678312
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698