Change of NLRP3 Inflammasome Expression Level, Symptoms, and Functional Status in Patients With Heart Failure With Preserved Ejection Fraction Treated With ARNI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks
研究概览
简要总结
Underlying inflammation has been increasingly recognized in heart failure with a preserved ejection fraction(HFpEF). But there is no study reported the relationship between NLRP3 inflammasome and HFpEF. In this study, investigators propose a scientific hypothesis that the expression of NLRP3 inflammasome is elevated in patients with HFpEF, and the level of TNFα, IL-1β and NLRP3 inflammasome is lower in patients treated with sacubitril/valsartan.
详细描述
The study will integrate data from two trials involving a total of 90 participants with heart failure. Depending on the using of ARNI, participants in HFpEF group will be divided into two groups. The diagnostic criteria for HFpEF is: (1) left ventricular ejection fraction ≥50%； (2）with the symptoms and/or signs of heart failure; (3) BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL; (4) at least one additional criterion: a.relevant structural heart disease(LVH and/or LAE); b.diastolic dysfunction. The primary outcome are the change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks. The key secondary outcomes include changes in echocardiographic measures, quality of life, etc. And then compare the rate of above indicators of two trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •left ventricular ejection fraction ≥50%；
- •with the symptoms and/or signs of heart failure；
- •BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
- •at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.
排除标准
- •LVEF less than 45% at any time;
- •severe infection;
- •pregnancy;
- •eGFR <30 mL/min/1.73 m2, etc.
结局指标
主要结局
The change from baseline in TNFα, IL-1β, NLRP3 inflammasome, and so on assessed at 12 weeks
时间窗: 12 weeks
Measuring the level of TNFα, IL-1β, NLRP3 inflammasome, and so on from blood samples at 12 weeks, seperately by PCR and ELISA
次要结局
- The change from baseline in echocardiographic measures and so on(12 months)
- The change from baseline in quality of life(12 months)
研究者
Dongying Zhang
Associate Professor
Chongqing Medical University