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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| finerenone group | Participants in Korea who are prescribed finerenone for treatment of chronic HF with left ventricular ejection fraction (LVEF) ≥40%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| finerenone (BAY94-8862) | Drug | According to the prescription of the participating patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at 1, 3, 6 and 12 months |
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Inclusion criteria:
Exclusion criteria:
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Adult chronic HF patients with LVEF ≥40% prescribed finerenone in routine clinical practice in Korea
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bayer Clinical Trials Contact | Contact | 1888842297 | clinical-trials-contact@bayer.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Recruiting | Multiple Locations | South Korea |
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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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C576501 | finerenone |
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| Time to dose change of finerenone |
| up to 12 months from baseline |