Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Change in estimated glomerular filtration rate(eGFR)
研究概览
简要总结
This paper will mainly present the renal results from a clinical study aimed to observe the effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart failure.All patients will receive LCZ696.The results will be compared before and after treatment.
详细描述
On trial entry, patients will first receive LCZ696 50mg twice daily.According to the condition of disease and tolerance,the dose will be doubled every 2 weeks until the target maintenance dose 200mg twice daily is reached unless potassium or change in kidney function preclude a dose increase(reduction in dose will be permitted if the larger dose will not be tolerated, and temporary interruption will be permitted at any time if required for clinical reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at 2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor participant safety).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with Chronic kidney disease (eGFR<60 ml/ min/1.73m²) and heart failure
- •documented history of heart failure with associated signs or symptoms
- •New York Heart Association (NYHA) classes II-IV
- •mean sitting systolic blood pressure (msSBP) ⩾140mmHg
- •good compliance
排除标准
- •isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac causes, primary valvular or myocardial diseases, or coronary or cerebrovascular diseases needing revascularization within 3months of screening or during the trial
- •acute renal failure
- •systolic blood pressure lower than 100 mm Hg at screening (<95 mm Hg at the randomisation visit)
- •significant laboratory abnormalities at screening interfering with assessment of study drug safety or efficacy(such as serum potassium>5.5 or <3.5mmol/L, serum sodium<130mmol/L or alanine aminotransferase or aspartate aminotransferase>2 times the upper limit of the normal range)
- •history of angioedema（drug-related or otherwise)
- •any medications that have potential for drug-drug interaction with LCZ696 will not be allowed during the study 7)pregnant female
研究组 & 干预措施
LCZ696 treatment
LCZ696 200mg twice daily
干预措施: LCZ 696 (Drug)
结局指标
主要结局
Change in estimated glomerular filtration rate(eGFR)
时间窗: 12 weeks
Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)
时间窗: 12 weeks
Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.
Change in urinary microalbumin/creatinine ratio(uACR)
时间窗: 12 weeks
Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.
次要结局
- left ventricle eject fraction(12 weeks)
- Concentration of serum troponin(12 weeks)
- Systolic and diastolic blood pressure(12 weeks)
- blood uric acid(12 weeks)
- Concentration of alanine aminotransferase or aspartate aminotransferase(12 weeks)
- Concentration of sodio(12 weeks)
- Rate of HbA1c(12weeks)
- Concentration of postassium(12 weeks)
研究者
Xuanyi Du
Principal Investigator
The Second Affiliated Hospital of Harbin Medical University