MedTrace Logo

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

NCT06697353 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4936

Last updated 2025-10-08

No results posted yet for this study

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

Interventions

DRUG

vericiguat (BAY 1021189)

2.5 mg initiating dose

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-09-19
Completion
2025-09-19

Countries

  • Japan

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06697353 on ClinicalTrials.gov