Post Marketing Surveillance for Finerenone Chronic Heart Failure in Korea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
研究组 & 干预措施
finerenone group
Participants in Korea who are prescribed finerenone for treatment of chronic HF with left ventricular ejection fraction (LVEF) ≥40%.
干预措施: finerenone (BAY94-8862) (Drug)
结局指标
主要结局
Number of adverse events (AEs)
时间窗: 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)
次要结局
- Change from baseline in investigator's treatment satisfaction(at 1, 3, 6 and 12 months)
- Time to dose change of finerenone(up to 12 months from baseline)