Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Composite CV mortality or HF hospitalization
研究概览
简要总结
There is limited long-term evidence specific to AAs with HFrEF on sacubitril/valsartan therapy. Plasma NT-proBNP levels are lower in AA individuals as compared to Caucasian individuals in general. However, the mechanism of action of sacubitril specifically targets the activity of BNP. Therefore, there is the potential that the mechanism of action of sacubitril/valsartan may be less effective in AAs.
详细描述
To assess the efficacy and safety of sacubitril/valsartan in AA patients with HFrEF by comparing the outcomes of AA patients on ARNI therapy plus SOC (with or without hydralazine/isosorbide [H-IDSN]) to AA patients receiving ACEi/ARB therapy plus SOC (with or without H-ISDN).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Self-identified as AA
- •NYHA class II-IV symptoms
- •Left ventricle EF <40%
- •Receiving stable doses of standard therapy, including ACE inhibitors or ARBs, ARNI (within a month from discharge), combination H-ISDN, beta blockers, digoxin, spironolactone, and diuretics as tolerated.
- •Patient must have minimum of three months follow-up
排除标准
- •Patients not meeting inclusion criteria
结局指标
主要结局
Composite CV mortality or HF hospitalization
时间窗: April 2017 to August 2020
Composite CV mortality or HF hospitalization
次要结局
- HF hospitalization(April 2017 to August 2020)
- New atrial fibrillation(April 2017 to August 2020)
- Renal function decline(April 2017 to August 2020)
- Change in EF(April 2017 to August 2020)
- Change in NYHA classification(April 2017 to August 2020)
- CV mortality(April 2017 to August 2020)
- All-cause mortality(April 2017 to August 2020)