The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- change in NTproBNP plasma concentration
研究概览
简要总结
The aim of this study is to evaluate the bio-clinical effects of sacubitril/valsartan combination in treatment of patients with Congestive heart failure. Moreover, the investigators aim to evaluate side effects of this combination.
- The following parameters were determined at baseline and at end of the study at 6 months of the beginning.
- New York Heart Association (NYHA) Class.
- Frequency of hospitalization by acute exacerbation of CHF
- NT-ProBNP
- Left ventricular systolic function by Echocardiography
Moreover, the side effects of the drugs used during study was assessed by
- Renal function (Serum creatinine) was performed every month till the end of the study.
- Serum electrolytes (Potassium and Sodium) was performed every month till the end of the study.
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
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 - 60 years
- •Patients with chronic congestive heart failure class ( II-IV) symptoms according to New York Heart Association (NYHA) classification
- •Left Ventricular Ejection Fraction of 40% or less.
- •NT-proBNP level of at least ≥400 pg per milliliter
- •ACE-inhibitor or ARB therapy with stable dose for prior 4 weeks, equivalent to enalapril ≥ 10 mg/day.
排除标准
- •Patients with symptomatic hypotension.
- •Pregnant and nursing women
- •Systolic blood pressure < 100 mmHg at screening or < 95 mmHg at randomization
- •Patients with glomerular filtration rate <30 mL/min/1.73 m2
- •Patients with history of angioedema
- •Patients with unacceptable side effects with ACE-inhibitors or ARBs.
研究组 & 干预措施
Sacubitril/valsartan
Group 30 patients will undergo treatment with sacubitril/valsartan combination according to guideline-directed medical therapy.
干预措施: Sacubitril-Valsartan (Drug)
Valsartan
Group 30 patients will undergo treatment with valsartan according to guideline-directed medical therapy.
干预措施: Valsartan (Drug)
结局指标
主要结局
change in NTproBNP plasma concentration
时间窗: at 6 months
NTproBNP is a Biomarker used to assess severity of congestive heart failure)
severity of congestive heart failure.
时间窗: at 6 months
Ejection fraction
次要结局
- change in serum sodium concentration(every month, up to 6 months)
- change in plasma potassium concentration(every month, up to 6 months)
- change in serum creatinine(every month, up to 6 months)
研究者
Amir Safwat
Teaching assistant
Suez Canal University