Observational study on vericiguat use in Korean patients with chronic heart failure
Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction
This study looks at how well vericiguat works and its safety for Korean adults with chronic heart failure who are already receiving their usual treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1350 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Trial ID | NCT06148935 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the use of vericiguat in patients with chronic heart failure with reduced ejection fraction (HFrEF) in a real-world setting in Korea. Participants will receive their usual treatment, and the study will focus on collecting important information regarding the effectiveness and safety of vericiguat. The study targets adults aged 19 and older who have been prescribed vericiguat and meet specific criteria related to their heart failure condition. By analyzing real-world data, the study seeks to enhance understanding of vericiguat's impact on HFrEF management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years or older with chronic heart failure and reduced ejection fraction who have been prescribed vericiguat.
Not a fit: Patients who are pregnant, have contraindications to vericiguat, or are participating in other investigational programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of vericiguat for managing chronic heart failure in Korean patients.
How similar studies have performed: Previous studies have shown success with vericiguat in treating heart failure, making this approach relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Multiple Locations
- Many Locations — Multiple Locations, South Korea (Recruiting)
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: (+)1-888-84 22937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.