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
NCT ID: NCT06148935
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2023-11-30
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Korean adult participants with HFrEF
Korean heart failure participants with reduced ejection fraction (HFrEF) who are prescribed Verquvo (Vericiguat) for an approved indication by the Ministry of Food and Drug Safety (MFDS) in Korea
Vericiguat (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
Interventions
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Vericiguat (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
Eligibility Criteria
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Inclusion Criteria
* Chronic HF (NYHA functional class II, III, or IV) Reduced left ventricular ejection fraction (\< 45%) within 12 months before enrollment
* Worsening of heart failure (hospitalized within 6 months before enrollment or intravenous diuretic therapy without hospitalization within 3 months)
* Participants who have been prescribed Verquvo (Vericiguat) as per locally approved label and didn't receive Verquvo (Vericiguat) therapy previously.
* Written informed consent from subject or legal representative; assent from subject when appropriate
Exclusion Criteria
* Participants participating in an investigational program with interventions outside of routine clinical practice
19 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many Locations
Multiple Locations, , South Korea
Countries
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Central Contacts
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Related Links
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Other Identifiers
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22013
Identifier Type: -
Identifier Source: org_study_id