NCT07047508尚未招募不适用
A Non-interventional Study of the Effectiveness and Safety Outcomes in Patients With Heart Failure and Preserved Ejection Fraction (HFpEF) Initiating Jardiance in China: A Sub-study of the Post-marketing Study of Jardiance Among Patients With Heart Failure in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,000
- 主要终点
- Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death
研究概览
简要总结
The main objective of the study is to describe the effectiveness and safety outcomes among Chinese hospitalized heart failure with preserved ejection fraction (HFpEF) patients initiating Jardiance® in the real-world setting.
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
- •At least 6 months of data prior to the index date
- •Left ventricular ejection fraction (LVEF) > 40 %
- •N-terminal Pro-B-type natriuretic peptide (NT-proBNP) > 125 pg/mL or brain natriuretic peptide (BNP) ≥ 35 pg/mL
- •At least 1 diagnosis of Heart failure with preserved ejection fraction (HFpEF) or Heart failure with mid-range ejection fraction (HFmrEF) or chronic heart failure (CHF) at baseline during the look-back period (on or prior to the index date)
- •New users of Jardiance® (initiating Jardiance® on or after March 1st, 2023, and without any record of Jardiance® prescription during the look-back period)
- •Body Mass Index (BMI) <45 kg/m2
排除标准
- •Patients treated with any other sodium-glucose cotransporter-2 inhibitors (SGLT2i) on the index date or during the look-back period
研究组 & 干预措施
Heart failure and preserved ejection fraction patients
结局指标
主要结局
Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death
时间窗: up to 2.5 years
HHF=Hospitalization for Heart Failure CV=cardiovascular
次要结局
- Incidence of CV death(up to 2.5 years)
- Occurrence of death from any cause(up to 2.5 years)
- Incidence of the HHF (the first HHF after the index date)(up to 2.5 years)
研究者
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