NCT07376265已完成不适用
Comparative Effectiveness of Sacubitril/Valsartan vs ACEi/ARB in HFrEF Patients: Real Heart PT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,249
- 试验地点
- 1
- 主要终点
- Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization
研究概览
简要总结
This was a retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in northern Portugal. The study aimed to assess the comparative effectiveness of sacubitril/valsartan (SAC/VAL) versus angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) in patients with heart failure with reduced ejection fraction (HFrEF).
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
- •Left ventricular ejection fraction (LVEF) < 40%
- •Brain natriuretic peptide (BNP) ≥35 pg/mL or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥125 pg/mL
- •Had a record in the database in the 365 days prior to the index date
排除标准
- •Missing sex or date of birth
- •Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 at SAC/VAL, ACEi or ARB initiation
- •History of angioedema or unacceptable side effects during receipt of SAC/VAL, ACEi or ARB
- •Severe hepatic impairment, biliary cirrhosis, and cholestasis
- •Pregnancy
研究组 & 干预措施
SAC/VAL Cohort
Adult patients with HFrEF undergoing therapy with SAC/VAL.
ACEi/ARB Cohort
Adult patients with HFrEF undergoing therapy with ACEi/ARB.
Missed Opportunities Cohort
Patients who were eligible for but did not receive SAC/VAL.
结局指标
主要结局
Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization
时间窗: 180 days, 810 days, 1260 days
次要结局
- Hazard Ratio for Death From Cardiovascular Causes(180 days, 810 days, 1260 days)
- Hazard Ratio for Hospitalization for Heart Failure(180 days, 810 days, 1260 days)
- Hazard Ratio for First Hospitalization or Emergency Room Visit(180 days, 810 days, 1260 days)
- Hazard Ratio for First Cardiovascular-specific Hospitalization(180 days, 810 days, 1260 days)
- Hazard Ratio for the Composite of Death From Cardiovascular Causes, Hospitalization for Heart Failure, Non-fatal Myocardial Infarction and Non-fatal Stroke(180 days, 810 days, 1260 days)
- Hazard Ratio for Implantable Cardioverter-defibrillator (ICD) Procedure(180 days, 810 days, 1260 days)
- Hazard Ratio for All-cause Mortality(180 days, 810 days, 1260 days)
- Hazard Ratio for Improved LVEF(180 days, 810 days, 1260 days)
- Pearson Correlation Coefficient Between Change From Baseline in NT-proBNP and LVEF(180 days, 810 days, 1260 days)
- Change From Baseline in NT-proBNP(180 days, 810 days, 1260 days)
- Change From Baseline in LVEF(180 days, 810 days, 1260 days)
- Total Healthcare Resource Utilization Costs per Calendar Year(Up to 5 years)
- Number of Days Patients Were Absent From Work per Calendar Year(Up to 5 years)
- Healthcare Resource Utilization Costs per Patient per Year(Up to 5 years)
- Hazard Ratio for Hyperkalemia(180 days, 810 days, 1260 days)
- Rate of Dose Titration Events per 100-Person-Years(180 days, 810 days, 1260 days)
- Rate of Patients Reaching the Maximum Dose per 100-Person-Years(180 days, 810 days, 1260 days)
- Rate of Treatment Discontinuation(180 days, 810 days, 1260 days)
- Number of Patients by Demographic Category(Baseline)
- Number of Patients by Clinical Characteristic Category(Baseline)
研究者
研究点 (1)
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