Many Locations
Multiple Locations, South Korea
Location status: Recruiting
NCT Number: NCT07379840
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.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Multiple Locations, South Korea
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
According to the prescription of the participating patient
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)
Time frame: at 1, 3, 6 and 12 months
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).
Time frame: up to 12 months from baseline
Contact information is provided by the study sponsor or research team.
Bayer
Industry
Post Marketing Surveillance for Finerenone Chronic Heart Failure in Korea
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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