Dapagliflozin Post-Marketing Surveillance in Heart Failure With Reduced Ejection Fraction Patients and Chronic Kidney Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 815
- 试验地点
- 1
- 主要终点
- Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs
研究概览
简要总结
This is an observational, non-interventional, single-arm multicenter study. The objectives of this study are to assess safety and effectiveness of Forxiga in a real world setting in patients who are prescribed with the study drug according to the newly approved indications in the Republic of Korea
详细描述
As part of a post-approval commitment, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (hereinafter "Korea") requests a study to characterize the safety in patients treated with dapagliflozin by physicians in normal clinical practice settings.
In principle, all patients treated (minimum of 900 required) with the product in accordance with the newly updated local prescribing information for HFrEF and/or CKD are eligible for the enrolment in this study. Product prescription and patient enrollment will depend on physicians' medical decision as per routine clinical practice. Patient follow-up will be 12 weeks or about 24 weeks (for long-term surveillance) and patients will be recruited over a period of 4 years after the new HFrEF indication approval by the local health authorities. This is due to the requirements from the local health authorities.
The primary objective of this study is to assess the safety profile of the product in Korean adult patients with heart failure with reduced ejection fraction (HFrEF) and/or chronic kidney disease (CKD) in a real world setting under the approved indication(s) in Korea.
The secondary objective of this study is to examine the effectiveness of the product, measured as: 1) no worsening in NYHA class, in Korean patients with HFrEF and/or 2) no worsening in UACR category in Korean CKD patients in a real world setting under the approved indication(s) in Korea.
The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with the safety and effectiveness of the product when prescribed under the approved indication(s) in Korean patients with HFrEF and/or CKD during the 12 weeks or about 24 weeks of follow-up duration
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients aged 19 years old and older
- •Patients eligible for the product treatment (i.e. on-label treatment) according to the newly approved HFrEF and/or CKD label in Korea
- •Provision of signed and dated written informed consent by the patient or legally acceptable representative
排除标准
- •Participation in any interventional trial during the treatment with the product.
- •Any off-label indications that are not in accordance with the newly approved label in Korea.
- •Any contraindications for the use of the product (as described in the local prescribing information).
- •Prior use of product, as per local MFDS guidance.
结局指标
主要结局
Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs
时间窗: 12weeks or 24weeks
次要结局
- No worsening in UACR category from baseline(12 weeks or 24 weeks)
- No worsening in NYHA class from baseline(12 weeks or 24 weeks)