NCT05737186终止4 期
The Efficacy and Safety of SGLT2 Inhibitors in Improving Heart Failure in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) and Severe Renal Insufficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The quality of Life
研究概览
简要总结
In the treatment of heart failure (HF), SGLT-2 inhibitor (SGLT-2i) can significantly improve the clinical outcome and quality of life related to HF. The current data show that SGLT-2i is effective and safe in improving HF outcomes in patients with chronic kidney disease (CKD) stage 4, but there is little clinical evidence in patients with eGFR<20 ml/min/1.73 m2. Therefore, our research is designed to confirm that SGLT-2i can improve the outcome of HF in patients with chronic heart failure with reduced ejection fraction (HFrEF) and severe chronic renal insufficiency (eGFR<20ml/min/1.73m2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-75 years
- •Patients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, New York Heart Association (NYHA) grade II-IV
- •Left ventricular ejection fraction (LVEF) ≤ 40% in the past 1 year
- •Clinically confirmed chronic renal insufficiency, eGFR<20ml/min/1.73m2 or maintenance hemodialysis
排除标准
- •Allergy to SGLT-2i
- •ALT or AST >3 times the upper limit of normal value; Or total bilirubin>2 times the upper limit of normal value
- •Urinary or reproductive system infection in the last month
- •Blood potassium is greater than or equal to the upper limit of normal value
- •Patients with acute heart failure
- •Patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics
- •Patients who need intravenous vasodilators, including nitrates, before randomization
- •Systolic blood pressure<100mmHg measured during screening or at randomization
- •Hemoglobin<90g/L
- •Uncontrolled serious arrhythmia
- •Myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization
- •Proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization
- •Patients with malignant tumors
- •Drug or alcohol addicts
- •Patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period
- •Pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period
- •Patients with uncontrolled abnormal thyroid function
- •Type 1 diabetes
- •Not suitable evaluated by the investigator
研究组 & 干预措施
Intervention group
Experimental
干预措施: SGLT-2 inhibitor (Drug)
结局指标
主要结局
The quality of Life
时间窗: 12 weeks
The change of Quality of Life in patients by using the The Kansas City Cardiomyopathy Questionnaire(KCCQ)
次要结局
- Dose changes of diuretics(12 weeks)
- The quality of Life(2 weeks, 4weeks and 8weeks)
- Changes of eGFR(2 and 12 weeks)
- Changes of brain natriuretic peptide (BNP)(12 weeks)
- Changes of body weight(12 weeks)
研究者
Ren qian
Associate Professor
Peking University People's Hospital
研究点 (1)
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