Effect of Sacubitril/Valsartan in Patients With Prosthetic Heart Valves With Heart Failure and Reduced Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Effective rate
研究概览
简要总结
This study aims to evaluate the effect of sacubitril/valsartan in patients with prosthetic heart valves with heart failure with reduced ejection fraction (HFrEF).
详细描述
Heart failure (HF) is the end stage of various types of cardiovascular disease. The prevalence of HF continues to rise, and the rates of readmission and mortality also continue to increase significantly.
There are three types of HF, heart failure with preserved ejection fraction (HFpEF), heart failure with mid-range ejection fraction (HFmrEF), and heart failure with reduced ejection fraction (HFrEF).
Sacubitril/valsartan, the first angiotensin receptor-neprilysin inhibitor (ARNI) approved by the FDA for the treatment of HFrEF, demonstrated significant benefits in the PARADIGM-HF trial. PARADIGM-HF trial was a large multicenter, randomized clinical trial comparing sacubitril/ valsartan with enalapril in patients with LVEF < 40%. This trial showed 20% reduction in composite Cardiovascular (CV) death (including sudden cardiac death) and hospitalization for HF patients with S/V.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Both sexes.
- •Patients with a history of prosthetic heart valves.
- •Patients diagnosed with heart failure with reduced ejection fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 40% with New York Heart Association (NYHA) functional class II-IV.
排除标准
- •Hemodynamic instability.
- •Use of a circulatory auxiliary circulation device.
- •Severe hepatic [alanine aminotransferase (ALT) >120 U/L] and renal insufficiency [estimated glomerular filtration rate (eGFR) <30 mL/min].
- •Blood pressure <100/60 mmHg.
- •Serum potassium >5.3 mmol/L.
- •Severe pulmonary hypertension.
- •Malignant arrhythmia.
- •Malignant tumor.
- •Known history of hereditary or primary angioedema.
- •Serious adverse drug reactions or serious complications over the course of treatment.
研究组 & 干预措施
Group S
Patients will be treated with conventional anti-heart failure therapy plus sacubitril/valsartan (oral administration of an initial dose of 24/26 mg twice daily, gradually increasing to 97/103 mg, depending on follow-up blood pressure) [Entresto, 100 mg (sacubitril 49 mg/valsartan 51 mg)].
干预措施: Sacubitril/Valsartan (Drug)
Group C
Patients will be treated only with conventional anti-heart failure therapy as a control group.
干预措施: Conventional anti-heart failure therapy (Drug)
结局指标
主要结局
Effective rate
时间窗: 6 months post-procedure
Effectiveness is defined as an New York Heart Association (NYHA) cardiac function grade improved by 1 grade or more. Effective rate= Effectiveness/total quantity\*(100%).
次要结局
未报告次要终点
研究者
Mohammed Ali Mohammed Hammad
Lecturer of Cardiology, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.
Kafrelsheikh University