Vericiguat Drug Use Two-arm Investigation in Chronic Heart Failure

What this Trial Is About

This research aims to learn more about the safety of the drug vericiguat in Japanese people with chronic heart failure, a condition where the heart does not pump blood as well as it should. Vericiguat is already approved for treatment, but limited information exists about its safety in a broader Japanese population and during long-term use. The study also compares how long vericiguat treatment may prevent cardiovascular death, such as from heart attack or stroke, compared to standard care. Participants will be divided into two groups: one group will receive vericiguat along with standard treatment for chronic heart failure, and the other group will continue with standard care without vericiguat. Vericiguat dosing will be determined by the treating doctor based on approved product guidelines. Data collection will cover up to two years of treatment or until no further information can be obtained, including adverse events and heart failure-related hospitalizations. During routine visits, researchers will collect data from medical records and electronic case report forms, including other diseases, prior medications, treatment duration, lab tests, vital signs, cardiac exams, hospitalizations, and any adverse events. The study will last six years in total, including analysis and data cleaning. The main outcomes measured include the severity, seriousness, outcome, and cause of adverse events in the vericiguat group, as well as cardiovascular death rates compared to the control group.

A Study to Learn More About the Safety of the Drug Vericiguat in Japanese People With Chronic Heart Failure Who Will be Receiving Vericiguat Under Real-world Conditions