Clinical Study Evaluating Efficacy and Safety Sacubitril-valsartan in Patients With Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- MACE incidence
研究概览
简要总结
The aim of this study is to evaluate the safety and efficacy of Sacubitril -Valsartan in patients with heart failure.
详细描述
- A 3-month, prospective interventional study, which will include 60 patients with heart failure reduced ejection fraction, patients, will be consecutively randomized into two groups, the first group (n=30) will be given Sacubitril-valsartan twice daily and the second group (n=30) on standard treatment of heart failure.
- Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. Patients will provided written informed consent and will be checked for inclusion and exclusion criteria.
- All patients will undergo analysis of inflammatory biomarkers such as: NT-proBNP, Galectin-3 and GDF-15 at beginning of the study and after 3 months of the study.
- Echocardiography study before and after the study focusing on:
Measurement of parameters such as: Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD), Ejection fraction (EF%).
- Follow up will be performed for assessing:
- MACE such as MI, stroke, HF, or death.
- LV Echocardiography improvements of any of basic Echo parameters.
- Assessment of New York Heart association (NYHA) class.
Outcomes: all patients will be followed up for 3 months for:
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old for both genders.
- •LV ejection fraction (LVEF) ≤40%.
- •Heart failure patients with NYHA grade II-IV.
排除标准
- •CKD with GFR < 20 ml/min/1.73
- •Serum potassium < 5.5 mmol / L.
- •Pregnant or lactating women
- •Active infection.
- •Congenital heart disease.
- •Autoimmune disorders or connective tissue disorders.
- •Severe hepatic dysfunction.
研究组 & 干预措施
Control group
Control group (n=30) on standard treatment of heart failure.
干预措施: standard treatment of heart failure (Drug)
Sacubitril-valsartan group
group (n=30) will be given Sacubitril-valsartan twice daily plus standard treatment.
干预措施: Sacubitril-valsartan (Drug)
结局指标
主要结局
MACE incidence
时间窗: 3 months
Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death.
Ejection fraction (EF%)
时间窗: 3 months
Ejection fraction (EF%) improvement.
次要结局
- NT-proBNP level (pg/ml)(3 months)
- Galectin-3 level (pg/ml)(3 months)
- GDF-15 level (pg/ml)(3 months)
研究者
Rehab Werida
Associate Professor
Damanhour University