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

Launched by BAYER · Dec 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medicine called vericiguat for Japanese people who have chronic heart failure, a condition where the heart struggles to pump blood properly. Vericiguat is already approved for use, but researchers want to learn more about how safe it is when used by a broader group of patients over a longer time. They will collect information about any health issues that arise during treatment, especially related to blood pressure, liver and kidney function, and other factors that could affect safety.

To participate, patients must be receiving standard treatment for chronic heart failure and have not previously taken vericiguat. They will need to give their consent to join the study. Throughout the trial, participants can expect regular check-ups where their health data will be recorded, including their medical history, medications, and any side effects they may experience. The study aims to gather data over two years, with a total duration of six years for analysis, to better understand how vericiguat can help manage heart failure while keeping patients safe.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• vericiguat arm:
• • Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat)
• • Patients who gave written consent to this investigation
• control arm:
• • Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat)
• • Prior (within 6 months) heart failure hospitalization or prior (within 3 months) intravenous (IV) diuretics for heart failure not requiring hospitalization (This will be applied only for the first \~75% of patients meeting this criteria to be enrolled.) Note: No more than approximately 25% of patients without a qualifying history of prior heart failure hospitalization within 6 months or prior IV diuretics for heart failure not requiring hospitalization within 3 months can be enrolled in the study.
• • New York Heart Association (NYHA) Classification: Class II to Class IV
• • Left ventricular ejection fraction (LVEF): less than 45%
• • Patients who gave written informed consent to this study
• Exclusion Criteria:
• vericiguat arm:
• • - Patients who are participating in an interventional study
• control arm:
• • Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure
• • Patients who are participating in an interventional study