Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction Patients: a Real World Study in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Age information
研究概览
简要总结
This was a non-interventional, retrospective EMR analysis of longitudinal prescriptions in India for a period of 1.5 years. Demographic profile of patients with heart failure with reduced ejection fraction on sacubitril/valsartan was recorded.
详细描述
Index date was date of 1st prescription of sacubitril/valsartan. Dose titration of sacubitril/valsartan was assessed for a period of 6 months post index date.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years with a diagnosis of HFrEF as mentioned in database or heart failure with a recording of LVEF <40% at or before the index date
- •A prescription of sacubitril/valsartan
排除标准
- •Diagnosis of HF specified as preserved/mid-range ejection fraction
研究组 & 干预措施
sacubitril/valsartan
Patients administered sacubitril/valsartan by prescription
干预措施: sacubitril/valsartan (Drug)
结局指标
主要结局
Age information
时间窗: Index date
Age information was reported
Gender information
时间窗: Index date
Gender information was reported
Number of Hospitalizations
时间窗: 1.5 years
Hospitalizations due to cardiovascular and non-cardiovascular causes
Number of patients with other treatments for heart failure
时间窗: 1.5 years
Other treatments for heart failure like implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT).
Functional Class (New York Heart Association (NYHA) classification)
时间窗: index date
The New York Heart Association Functional Classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity; the limitations/symptoms are in regard to normal breathing and varying degrees in shortness of breath and/or angina.
Classification of Heart Failure by etiology
时间窗: 1.5 years
Coronary artery disease, valvular, rheumatic heart disease, others, unknown.
Change in ventricular function defined by Left Ventricular Ejection Fraction (LVEF)
时间窗: Index date, 1.5 years
An ejection fraction (EF) is the volumetric fraction (or portion of the total) of fluid ejected from a chamber with each contraction (or heartbeat).
Number of participants with notable changes in laboratory parameters
时间窗: Baseline, 1.5 years
Safety measured by the notable post-baseline changes in laboratory parameters compared to baseline
Number of participants by Geographic area
时间窗: idex date
Geographic area divided into 4 zones- North, South, East and West
Body Mass Index
时间窗: Index date
Median value body mass index was reported
Medical History
时间窗: 1.5 years
type 2 diabetes, chronic obstructive pulmonary disease (COPD), anemia, chronic renal disease, atrial fibrillation, stroke, hypertension, myocardial infarction
Number of participants with concomitant medications
时间窗: up to 6 months pre index date, Up to 6 months post index date
Concomitant medications classified as- * Medications for HF: Diuretics, digitalis, beta-Blockers, ACEi, ARBs, MRA, ivabradine, SGLT2 inhibitors. * Medications for non-HF conditions: Anti-diabetic medications other than SGLT2 inhibitors (oral and injectable), statin, antiplatelet therapy, oral anti-coagulants.
次要结局
- Persistence to sacubitril/valsartan(Up to 12 months post index date)
- Proportion of patient discontinuing sacubitril/valsartan(month 2, month 4, month 6, month 8 and month 12)
- Maximum individual dose reached(6 months post index date)
- Time to target dose(6 months post index date)
- Time to first dose up-titration(6 months post index date)
- Individual dose(6 months post index date)
- Titration patterns(1.5 years)
- Proportion of patients being titrated to 100mg from 50mg(1.5 years)
- Proportion of patients being titrated to 200mg from 100mg(1.5 years)