Exploring the Efficacy and Safety of Dapagliflozin in Improving Heart Failure in Dialysis Patients: an Open, Prospective, and Self-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- N-terminal B-type natriuretic peptide precursor (NT-proBNP)
研究概览
简要总结
Dialysis patients have a higher incidence of cardiovascular events and require more effective measures to delay the progression of heart failure. Many studies have shown that dapagliflozin has cardioprotective effect, but most studies focus on non-dialysis patients with eGFR more than 20ml/min/1.73m2. However, the data on patients with eGFR less than 20ml/min/1.73m2 or dialysis patients, especially peritoneal dialysis patients, is less. Exploring the efficacy and safety of Dapagliflozin in improving heart failure in dialysis patients is of great clinical significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age between 20 and 70 years old; 2.Maintenance dialysis for longer than 3 months; 3.Diagnosis with chronic heart failure, Left ventricular ejection fraction (LVEF)≤40% or NT-proBNP>12000pg/ml; 4.The patient signs an informed consent form.
排除标准
- •1.Patients with liver function impairment; 2.Patients with severe hypoglycemia/hypotension/ketoacidosis; 3.Patients with active pyelonephritis or symptomatic urinary tract infection; 4.Dapagliflozin allergies or severe adverse reactions; 5.Patients suffering from other severe diseases; 6.Patients participating in other clinical trials; 7.Pregnant or lactating women; 8.Failure to sign a written informed consent form; 9.Unable or unwilling to comply with the experimental protocol approved by the researcher
研究组 & 干预措施
Self Control
Compare the heart function of dialysis patients before treatment and during the third and sixth months of treatment.
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
N-terminal B-type natriuretic peptide precursor (NT-proBNP)
时间窗: Baseline, 3 months, 6 months
Changes in NT-proBNP levels before and after treatment
Left ventricular ejection fraction (LVEF)
时间窗: Baseline, 3 months, 6 months
Changes in LVEF levels before and after treatment
次要结局
未报告次要终点
研究者
deng shanshan
Researcher
The People's Hospital of Gaozhou