A Phase 3, Single-arm, Open-label Extension of the Vericiguat VALOR Study in Pediatric Participants with Heart Failure due to Systemic Left Ventricular Systolic Dysfunction (VALOR EXT)

This study is a continuation for children who are already taking part in a research project looking at a medicine called Vericiguat. This medicine is for children who have a specific type of heart failure where their left ventricle – which is the heart's main pumping chamber – isn't squeezing blood out as strongly as it should. Because the children are continuing to take the medicine, this study is mainly focused on checking how well they tolerate it over time.

The main thing researchers want to find out is how safe Vericiguat is for children. They will be very carefully looking at any side effects that participants might experience. This includes minor issues as well as more serious ones. They will also track how many children need to stop taking the medicine because of these side effects. This information is really important for doctors to understand if the medicine is well-tolerated by young people.

While the main focus is on safety, the study will also look at a specific blood test called NT-proBNP. This test can give doctors an idea of how much strain there is on the heart. Researchers will compare the results of this blood test from the start of this extension study to 16 weeks later. This helps them see if the medicine is having any impact on this heart marker over time, although safety is the primary concern.