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ID05666518

Observational Study Evaluating the Safety of Vericiguat Compared to Standard Treatment in Japanese Patients with Chronic Heart Failure

Led by Bayer · Updated on 2026-07-06

1400

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

This observational study focuses on Japanese people with chronic heart failure who are receiving the drug vericiguat. Chronic heart failure is a long-term condition where the heart does not pump blood effectively, which can lead to serious health issues, hospitalization, or death. Researchers aim to learn more about the safety of vericiguat in a broader Japanese population and during prolonged treatment, especially since limited patients have received this drug so far. Participants include those who will start vericiguat therapy alongside standard treatment and those continuing standard care without vericiguat. The dosing of vericiguat is determined by the treating physician based on approved product information. The study collects data from medical records and electronic forms during routine medical visits over a period of up to two years. It compares the safety and cardiovascular outcomes, such as death from heart-related causes, between those treated with vericiguat and those receiving standard care. During the study, researchers will document participants medical history, treatments, laboratory results, vital signs, cardiac exam results, hospitalizations related to heart failure, and any adverse events experienced. The studys main focus is on the severity, seriousness, outcome, and causes of adverse events related to vericiguat treatment. The total study duration, including data analysis, is six years, allowing for long-term safety monitoring and evaluation of treatment effects.

CONDITIONS

Brief Title

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

Research Team

B

Bayer Clinical Trials Contact

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