Effect of Bilirubin on Prognosis in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The level of direct bilirubin
研究概览
简要总结
Factors influencing the prognosis of patients with heart failure with preserved ejection fraction (HFpEF) have been extensively studied. Previous studies have found that elevated serum total bilirubin levels are associated with cardiac death, heart failure readmission, and all-cause mortality in patients with chronic heart failure. However, the relationship between direct bilirubin and prognosis in patients with HFpEF is unclear.
详细描述
Patients with heart failure with preserved ejection fraction account for approximately 50% of all heart failure patients, have approximately 1.4 hospitalisations per year and an annual mortality rate of approximately 15%. Till now, there have no definitively proven therapies that can reduce their morbidity and mortality, HFpEF Patients have a poor prognosis. The current study found that the prognosis of patients with HFpEF may be related to the heterogeneity of the disease, its various phenotypes and multifactorial pathophysiology, which has not been fully elucidated. The current study found that bilirubin is a risk factor for adverse outcomes of various HFpEF-related complications, but the relationship between direct bilirubin and prognosis of HFpEF has not been reported. Therefore the investigators speculate that direct bilirubin is a predictor of prognosis of HFpEF patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult aged ≥18 years old；
- •Diagnosed with HFpEF.
- •Diagnostic criteria including:
- •left ventricular ejection fraction ≥ 50%;
- •with the symptoms and/or signs of heart failure;
- •Patients in sinus rhythm：BNP≥35pg/ml and/or NT-proBNP≥125pg/ml；Patients with atrial fibrillation：BNP≥105pg/ml and/or NT-proBNP≥365pg/ml.
排除标准
- •LVEF less than 49% at any time
结局指标
主要结局
The level of direct bilirubin
时间窗: The day when patients on admission
The level of direct bilirubin
a composite of heart failure rehospitalization or all-cause mortality
时间窗: In an average of 3 year after discharge
a composite of heart failure rehospitalization or all-cause mortality
次要结局
- heart failure rehospitalization(In an average of 3 year after discharge)
- all-cause mortality(In an average of 3 year after discharge)
研究者
Dongying Zhang
Clinical Professor
Chongqing Medical University