NCT06697353

An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan

ROVER Japan/ Real-world Outcomes of Patients Treated With Vericiguat in Japanese Routine Care: a Retrospective Cohort Study Using a Hospital Administrative Database

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,936 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study in which data already collected from people with chronic heart failure is studied. Chronic HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays or even death. The study drug, vericiguat, is already approved for doctors to prescribe to people with chronic HFrEF in Japan. Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better. The participants in this study are already receiving treatment with vericiguat (newly initiated) as part of their regular care from their doctors. There is currently limited real-world data on the use of vericiguat in Japanese people. Therefore, more research is needed on larger groups of Japanese people for a longer period to understand the effects of use of vericiguat. The main purpose of this study is to collect information about how well vericiguat is used in Japanese people with heart failure who initiate vericiguat treatment. To do this, researchers will collect the following information for participants who newly initiated vericiguat: occurrence of death due to heart and blood vessel related events occurrence of death due to any reason hospital stays due to heart failure a combination of hospital stays due to heart failure or occurrence of death due to heart and blood-vessel related events a combination of occurrence of death due to any reason or hospital stays due to heart failure In addition, researchers will collect the following information: participants' characteristics, including age, sex, height, weight, and medical history how well did the participants follow their prescribed treatment with vericiguat over the year after starting it how long did the participants continue to take vericiguat over the year after starting it changes in the dose of vericiguat in the participants over the year after starting it other treatment options participants have taken for the treatment of heart failure changes in laboratory values and other test results before and after treatment with vericiguat The data will come from the participants' hospital records provided by the Medical Data Vision Co., Ltd. They will cover the period from September 2016 to July 2024. Researchers will track participants' data and will follow them for a maximum of one year after starting treatment with vericiguat, or until any of the following happens: the participant dies the participant cannot be tracked anymore the end of the study In this study, only available data from routine care are collected. No visits or tests are required as part of this study.

Conditions

• Chronic Heart Failure
• Chronic Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	vericiguat (BAY 1021189)	2.5 mg initiating dose

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-09-19
• Completion: 2025-09-19
• First posted: 2024-11-20
• Last updated: 2025-10-08

Locations

1 site across 1 country: Japan