Non-interventional Study of the Effectiveness and Safety of Jardiance in Patients With Heart Failure (HF) of Reduced Ejection Fraction (HFrEF) Compared to Guideline-recommended Non-SGLT2i Therapy Regimens in China: A Sub-study of the Postmarketing Study of Jardiance Among Patients With Heart Failure in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Time from the index date to the first hospitalisation for heart failure (HHF) or cardiovascular (CV) death
研究概览
简要总结
This study is to provide the effectiveness and safety evidence in patients with heart failure of reduced ejection fraction (HFrEF) initiating Jardiance in real clinical practice in a larger Chinese population.
The primary objective is to compare the risk of the composite outcome of cardiovascular (CV) death or hospitalisation for heart failure (HHF) in heart failure with reduced ejection fraction (HFrEF) patients initiating Jardiance with propensity score (PS) matched HFrEF patients initiating guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (SGLT2i) medications (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) in China, measured by the hazard ratio of the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Has at least 1 diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) at baseline during the 6-month look-back period (on or prior to the index date)
- •Left Ventricular Ejection Fraction (LVEF) ≤40%
- •N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) >125pg/mL or Brain Natriuretic Peptide (BNP)≥35 pg/mL
- •New users of Jardiance or guideline-recommended non-Sodium-glucose Cotransporter-2 inhibitors (SGLT2i) medications (Angiotensin-converting-enzyme inhibitors (ACEi)/Angiotensin II Receptor Blocker (ARB)/ Angiotensin Receptor-neprilysin Inhibitor (ARNI), beta-blockers, and Mineralocorticoid Receptor Antagonist (MRA)) for HFrEF, who had not used the respective index drug during the look-back period
- •Baseline data during the look-back period or on the index date have been collected
- •Body mass index (BMI) <45 kg/m2
排除标准
- •Patients treated with any SGLT-2i during the look-back period
- •Patients treated with any other SGLT-2i on the index date
研究组 & 干预措施
Patients initiating Jardiance
Initiation of Jardiance for heart failure of reduced ejection fraction (HFrEF) treatment after the launch of HFrEF indication in China
干预措施: Jardiance (Drug)
Patients initiating other non-SGLT2i medications (ACEi/ARB/ARNI, beta-blockers, and MRA)
Initiation of a different guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (non-SGLT2i) medication class (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) for HFrEF treatment, after the launch of HFrEF indication of Jardiance in China
干预措施: non-SGLT2 inhibitors (Drug)
结局指标
主要结局
Time from the index date to the first hospitalisation for heart failure (HHF) or cardiovascular (CV) death
时间窗: From the index date to the end date of each individual's follow-up, up to 3 years
Time from the index date to the first hospitalisation for heart failure (HHF) or cardiovascular (CV) death
时间窗: From the index date to the end date of each individual's follow-up, up to 3 years
次要结局
- Total number of HHFs at 30 days after the index date(At 30 days after the index date)
- Total number of HHFs at 90 days after the index date(At 90 days after the index date)
- Time from the index date to cardiovascular (CV) death(From the index date to the end date of each individual's follow-up, up to 3 years)
- Total number of HHFs at 1 year after the index date(At 1 year after the index date)
- Time from the index date to the first hospitalisation for heart failure (HHF)(From the index date to the end date of each individual's follow-up, up to 3 years)
- Time from the index date to all-cause death(From the index date to the end date of each individual's follow-up, up to 3 years)
- Time from the index date to cardiovascular (CV) death(From the index date to the end date of each individual's follow-up, up to 3 years)
- Total number of HHFs at 1 year after the index date(At 1 year after the index date)
- Time from the index date to all-cause death(From the index date to the end date of each individual's follow-up, up to 3 years)