RecruitingNCT06148935

An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in Real-world Setting

Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction


Sponsor

Bayer

Enrollment

1,350 participants

Start Date

Nov 30, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood 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 and death. The study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment. Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected: * occurrence of death due to heart and circulatory events * hospital stays due to heart conditions (failure) * dose levels of vericiguat and duration of treatment The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking how a heart failure medication called vericiguat (brand name Verquvo) is used in real-world clinical practice in Korea. It is not testing a new drug — it is observing people who have already been prescribed vericiguat by their doctor to learn more about how it works outside of a clinical trial setting. **You may be eligible if...** - You are 19 years old or older - You have chronic heart failure (NYHA class II, III, or IV) with a reduced ejection fraction (less than 45%) confirmed within the past 12 months - Your heart failure has recently worsened — either requiring hospitalization in the past 6 months, or requiring IV diuretics (water pills given through a vein) in the past 3 months without hospitalization - You have been newly prescribed vericiguat (Verquvo) by your doctor and have never taken it before **You may NOT be eligible if...** - You have a known allergy or sensitivity to vericiguat or are pregnant - You are currently taking part in another experimental clinical study with interventions that go beyond standard care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVericiguat (Verquvo, BAY1021189)

Following the manner of observational study, no intervention will be provided in the study. Participants follow locally approved label, without interference by the study initiator or study protocol


Locations(1)

Many Locations

Multiple Locations, South Korea

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NCT06148935


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