A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Jardiance® (Empagliflozin, 10mg) in Korean Patients With Chronic Heart Failure (NYHA Class II-IV)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 676
- 试验地点
- 21
- 主要终点
- Number of Patients With Adverse Events (AEs)
研究概览
简要总结
The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.
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
- •Patients who have started at first time on Jardiance® in accordance with the approved label in Korea for heart failure (HF)
- •Chronic heart failure (New York Heart Association (NYHA) class II-IV)
- •Age ≥ 19 years at enrolment
- •Patients who have signed on the data release consent form
排除标准
- •Patients with previous exposure to Jardiance®
- •Known allergy or hypersensitivity to active ingredients empagliflozin or to any of the excipients
- •Patients with type 1 diabetes or with prior history of diabetic ketoacidosis (DKA)
- •Patient with renal impairment with estimated Glomerular Filtration Rate (eGFR) < 20 mL/min/1.73 m²
- •Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Patient who are pregnant or are nursing or who plan to become pregnant while in the trial
- •Patients for whom empagliflozin is contraindicated according local label of Jardiance®
研究组 & 干预措施
JARDIANCE® treated patients
Patients in Korea with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus).
干预措施: JARDIANCE® (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs)
时间窗: Up to 407 days.
Number of patients with adverse events (AEs) is reported.
Number of Patients With Unexpected Adverse Events
时间窗: Up to 407 days.
Number of patients with unexpected adverse events is reported.
Number of Patients With Unexpected Adverse Drug Reaction
时间窗: Up to 407 days.
Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.
Number of Patients With Serious Adverse Events
时间窗: Up to 407 days.
Number of patients with serious adverse events is reported.
Number of Patients With Serious Adverse Drug Reaction
时间窗: Up to 407 days.
Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.
Number of Patients With Drug-related Adverse Events
时间窗: Up to 407 days.
Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.
Number of Patients With Non-serious Adverse Drug Reaction
时间窗: Up to 407 days.
Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.
Number of Patients With Adverse Event of Special Interest
时间窗: Up to 407 days.
Number of patients with adverse event of special interest is reported.
Number of Patients With Adverse Events Leading to Discontinuation
时间窗: Up to 407 days.
Number of patients with adverse events leading to discontinuation is reported.
次要结局
- Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline(Data collected at baseline (visit 1), week 12 and week 24.)
- Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment(Data collected at week 12 and week 24.)
- Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment(At baseline and at week 12.)
- Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment(At baseline and at week 24.)
- Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline(Data collected at baseline (visit 1), week 12 and week 24.)
- Changes in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at 12 Weeks and 24 Weeks Compared to Baseline(Data collected at baseline (visit 1), week 12 and week 24.)
- Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment(Data collected at baseline (visit 1), week 12 and week 24.)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks and 24 Weeks of Treatment(Data collected at baseline (visit 1), week 12 and week 24.)
- Change From Baseline in Body Weight After 12 Weeks and 24 Weeks of Treatment(Data collected at baseline (visit 1), week 12 and week 24.)
- Change From Baseline in Systolic Blood Pressure (SBP) After 12 Weeks and 24 Weeks of Treatment(Data collected at baseline (visit 1), week 12 and week 24.)
- Change From Baseline in Diastolic Blood Pressure (DBP) After 12 Weeks and 24 Weeks of Treatment(Data collected at baseline (visit 1), week 12 and week 24.)
- The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment(Data collected at baseline (visit 1), week 12 and week 24.)