Safety of finerenone in adults with chronic heart failure (LVEF ≥ 40%) in South Korea
Official title: Post Marketing Surveillance for Finerenone Chronic Heart Failure in Korea
Run by Bayer · NCT07379840 · Data updated 2026-11-12
This project will see if finerenone is safe for adults in South Korea who have chronic heart failure with a left ventricular ejection fraction of 40% or higher while they take it as usual care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Bayer Industry-sponsored |
| Locations | 1 site (Multiple Locations) |
| Status | Recruiting |
| Started | December 23, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | February 3, 2026 |
| Trial ID | NCT07379840 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19 or older in South Korea with chronic heart failure and LVEF ≥ 40% who are being prescribed finerenone for the first time and can give informed consent.
✕Probably not a fit
People who are not prescribed finerenone, have contraindications to the drug, are already taking finerenone, participate in other interventional trials, or have LVEF below 40% are unlikely to receive direct benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational post-marketing study collects routine clinical data from adults in South Korea who are prescribed finerenone for chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40%. Participants receive finerenone as part of their normal care and investigators record safety data such as adverse events, laboratory results, and concomitant medication use without changing treatment. Enrollment is limited to finerenone-naïve adults aged 19 or older who provide informed consent and meet local labeling criteria, excluding those with contraindications or in other interventional programs. The goal is to describe real-world safety and tolerability of finerenone across multiple clinical sites in South Korea.
Why it matters
Potential benefit: If successful, the study could provide real-world safety information that helps patients and doctors feel more confident using finerenone in people with chronic heart failure and LVEF ≥ 40%.
How similar studies have gone: Randomized trials of finerenone in related populations have provided safety data and post-marketing surveillance is commonly used to confirm real-world safety, although specific real-world evidence in heart failure with LVEF ≥ 40% is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Adults aged 19 years or older * With informed consent from subject or legal representative (Prioritizing patient consent) * Finerenone naïve patients who are prescribed finerenone for treatment of chronic HF with LVEF ≥40% Exclusion criteria: * Contraindication according to the local label (including known hypersensitivity to the drug substance or any of its components) * Patients participating in an investigational program with interventions outside of routine clinical practice (NYHA classes II-IV) in accordance with local label
Where it's running
-
Many Locations
Multiple Locations, South Korea Recruiting
Study contacts
- Study coordinator: Bayer Clinical Trials Contact
- Email: clinical-trials-contact@bayer.com
- Phone: 1888842297
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.