Protocol Title: A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction Consistent with Dilated Cardiomyopathy (VALOR)

This is a Phase 2/3 adaptive randomized, placebo-controlled, parallel-group, multisite, double-blind study of vericiguat in pediatric participants with HF due to LV systolic dysfunction consistent with dilated cardiomyopathy. This study will enroll 4 staggered age cohorts: -Cohort 1: 12 to <18 years of age -Cohort 2: 6 to <12 years of age -Cohort 3: 2 to <6 years of age -Cohort 4: >28 days to <2 years of age Approximately 342 participants will be randomized to vericiguat or matching placebo on a background of medical therapy for HF. Randomization will be stratified by age cohort and by screening NT-proBNP <=1000 pg/mL versus >1000 pg/mL. An NT-proBNP level of greater than1000 pg/mL identifies the subpopulation of pediatric HF patients at higher risk of poor outcome {05M8XZ, 05M8WW}, The minimum number of participants to be randomized in each age group is as follows: -At least 50 participants in Cohort 1 (12 to <18 years of age) -At least 50 participants in Cohorts 2 and 3 combined (2 to <12years of age) -At least 20 participants in Cohort 4 (>28 days to <2 years of age) A randomization cap may be applied to one or more age cohorts in order to ensure adequate representation of all age cohorts. n each age cohort, participants enrolled into the Phase 2 portion of the study will be randomized in a 2:1 ratio to enrich the number of PK samples collected in vericiguat participants. This initial vanguard of participants will consist of ~18 participants in each age cohort and will be called the Intensive PK Group. Once dose review is completed for this Intensive PK Group, additional participants enrolling directly into Phase 3 will be randomized in a 1:1 ratio.