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

Bayer

Status: Enrolling

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Treatments: Drug: Vericiguat (Verquvo, BAY1021189)

Study type: Observational

Funder types: Industry

Identifiers

NCT06148935

22013

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult aged 19 years or older
• 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

• Contraindication according to the local authorized label (including known hypersensitivity to the drug substance or any of its components, pregnancy)
• Participants participating in an investigational program with interventions outside of routine clinical practice

Trial design

3,000 participants in 1 patient group

Korean adult participants with HFrEF

Description:

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

Treatment:

Drug: Vericiguat (Verquvo, BAY1021189)