Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Number of Subjects With Adverse Drug Reactions (ADRs)
研究概览
简要总结
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic heart failure (CHF) failure who are prescribed with JARDIANCE® Tablets in Japan
- •Patients who have never been treated with Empagliflozin (including treatment for type 2 diabetes mellitus (T2DM)) before enrolment
排除标准
- 未提供
研究组 & 干预措施
JARDIANCE®
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® tablets and who were never treated with Empagliflozin before enrolment. Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
干预措施: JARDIANCE® (Drug)
结局指标
主要结局
Number of Subjects With Adverse Drug Reactions (ADRs)
时间窗: Up to 52 weeks
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).
次要结局
- Incidence of All-cause Death(Up to 52 weeks)
- Incidence of Cardiovascular Death(Up to 52 weeks)
- Incidence of Hospitalizations for Heart Failure(Up to 52 weeks)