Chronic Heart FailureNCT07379840
A Study to Learn More About How Safe Finerenone is and How Well it Works in Adults With Chronic Heart Failure in South Korea
An observational study of Chronic Heart Failure, run by Bayer at 1 site in South Korea.
Trial summary
This is an observational study in which data from people with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. who will be receiving finerenone are studied. The study is conducted to check the safety of finerenone after it is approved and available in South Korea. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- finerenone (BAY94-8862)
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Dec 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult chronic HF patients with LVEF ≥40% prescribed finerenone in routine clinical practice in Korea
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Many Locations
Multiple Locations
About this study
Official title: Post Marketing Surveillance for Finerenone Chronic Heart Failure in Korea
This is an observational study in which data from people with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. who will be receiving finerenone are studied.
The study is conducted to check the safety of finerenone after it is approved and available in South Korea.
Read more
Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study.
In this study, the data will be collected from participants who are receiving their usual treatment with finerenone as prescribed by their doctor according to the approved product information.
Heart failure with LVEF ≥ 40% is a condition which occurs when the left side of the heart does not pump blood out to the body as well as it should. Over time, the body does not get the amount of oxygen it needs. This can lead to shortness of breath and tiredness, making it difficult for people to do their daily tasks.
The study drug, finerenone, is already approved for doctors to prescribe to people with chronic heart failure. It works by blocking a specific receptor in the body called the mineralocorticoid receptor (MR). This helps reduce harmful effects in the heart, kidneys and blood vessels. Finerenone is different from older medicines in this group because it is more selective and may have fewer side effects, such as problems with the kidneys or high potassium levels in the blood.
The participants in this study will receive finerenone as prescribed independently by their doctors during routine practice according to the approved product information.
There have been studies in which researchers studied the effect and safety of finerenone in participants with chronic heart failure with LVEF ≥ 40%. These studies, however, included only a small number of South Korean participants. In this study, researchers will specifically gather data from South Korean participants to further understand the safety of finerenone.
The main purpose of this study is to learn more about how safe and effective finerenone is in adults with chronic heart failure with LVEF ≥ 40% in South Korea within approved local label when used in everyday medical practice.
To do this, researchers will collect any side effects or health problems that happen while patients are taking finerenone, and whether they are related to finerenone.
In addition, doctors will also look at how well finerenone works by measuring:
- Changes in investigator's treatment satisfaction with the treatment over time, including improvements in symptoms, quality of life and overall health status.
- Time to dose change of finerenone (for example, increasing the dose if needed).
Data will be collected from participants over one year after they enroll in the study or until they choose to leave the study. The data will come from participant's medical records or by interviewing the patient.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
- Conditions
- Chronic Heart Failure
- Being tested
- finerenone (BAY94-8862)
- Keywords
- Heart Failure, Post-Marketing Surveillance
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
finerenone (BAY94-8862)Drug
According to the prescription of the participating patient
| Study group | Role | What they receive |
|---|---|---|
| finerenone group | Participants in Korea who are prescribed finerenone for treatment of chronic HF with left ventricular ejection fraction (LVEF) ≥40%. Receives: Drug: finerenone (BAY94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events (AEs)
including treatment emergent adverse events (TEAEs), adverse drug reactions (ADRs), unexpected AEs, unexpected ADRs, serious adverse events (SAEs), serious adverse drug reactions (SADRs), adverse events of special interest (AESI)
Measured: 12 months from baseline
Secondary outcomes (2)
Change from baseline in investigator's treatment satisfaction
Investigator's treatment satisfaction will be assessed on a 7-point Likert-type scale ([1] Strongly agree; [2] Agree; [3] More or less agree; [4] Undecided; [5] More or less disagree; [6] Disagree; [7] Strongly disagree).
Measured: at 1, 3, 6 and 12 months
Time to dose change of finerenone
Measured: up to 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start23 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379840
- Sponsor's protocol ID
- 23041
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance for Finerenone Chronic Heart Failure in Korea
- ClinicalTrials.gov ID
- NCT07379840
- Acronym / sponsor ID
- 23041
- Conditions
- Chronic Heart Failure
- Keywords
- Heart Failure, Post-Marketing Surveillance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational study in which data from people with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. who will be receiving finerenone are studied.
The study is conducted to check the safety of finerenone after it is approved and available in South Korea.
Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study.
In this study, the data will be collected from participants who are receiving their usual treatment with finerenone as prescribed by their doctor according to the approved product information.
Heart failure with LVEF ≥ 40% is a condition which occurs when the left side of the heart does not pump blood out to the body as well as it should. Over time, the body does not get the amount of oxygen it needs. This can lead to shortness of breath and tiredness, making it difficult for people to do their daily tasks.
The study drug, finerenone, is already approved for doctors to prescribe to people with chronic heart failure. It works by blocking a specific receptor in the body called the mineralocorticoid receptor (MR). This helps reduce harmful effects in the heart, kidneys and blood vessels. Finerenone is different from older medicines in this group because it is more selective and may have fewer side effects, such as problems with the kidneys or high potassium levels in the blood.
The participants in this study will receive finerenone as prescribed independently by their doctors during routine practice according to the approved product information.
There have been studies in which researchers studied the effect and safety of finerenone in participants with chronic heart failure with LVEF ≥ 40%. These studies, however, included only a small number of South Korean participants. In this study, researchers will specifically gather data from South Korean participants to further understand the safety of finerenone.
The main purpose of this study is to learn more about how safe and effective finerenone is in adults with chronic heart failure with LVEF ≥ 40% in South Korea within approved local label when used in everyday medical practice.
To do this, researchers will collect any side effects or health problems that happen while patients are taking finerenone, and whether they are related to finerenone.
In addition, doctors will also look at how well finerenone works by measuring:
- Changes in investigator's treatment satisfaction with the treatment over time, including improvements in symptoms, quality of life and overall health status.
- Time to dose change of finerenone (for example, increasing the dose if needed).
Data will be collected from participants over one year after they enroll in the study or until they choose to leave the study. The data will come from participant's medical records or by interviewing the patient.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| finerenone group | – | Drug: finerenone (BAY94-8862)Participants in Korea who are prescribed finerenone for treatment of chronic HF with left ventricular ejection fraction (LVEF) ≥40%. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult chronic HF patients with LVEF ≥40% prescribed finerenone in routine clinical practice in Korea
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| finerenone (BAY94-8862)According to the prescription of the participating patient | Drug | finerenone group |
Primary outcome
Number of adverse events (AEs)
Time frame: 12 months from baseline
including treatment emergent adverse events (TEAEs), adverse drug reactions (ADRs), unexpected AEs, unexpected ADRs, serious adverse events (SAEs), serious adverse drug reactions (SADRs), adverse events of special interest (AESI)
2 secondary outcomes
Change from baseline in investigator's treatment satisfaction
Time frame: at 1, 3, 6 and 12 months
Time to dose change of finerenone
Time frame: up to 12 months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. Currently, there is no established plan for the sharing of Individual Patient Data (IPD) from this study. The availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA 'Principles for responsible clinical trial data sharing.' This pertains to the scope, timepoint, and process of data access. As such, Bayer commits to considering requests from qualified researchers for patient- / study-level clinical trial data, and documents from clinical trials involving medicines and indications approved in the US and EU. However, this commitment does not reflect an active IPD sharing plan. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Researchers can use www.vivli.org to request access to IPD and documents from clinical studies to conduct research. Information on Bayer's criteria for listing studies is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Bayer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact (1888842297, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (AEs) (time frame: 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.