Influence of Sacubitril/Valsartan on Autonomic Cardiac Nervous System in Heart Failure Patients: an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Changes in serum potassium level (mmol/l)
研究概览
简要总结
Sacubitril/valsartan is an angiotensin receptor neprilysin inhibitor with the ability to reduce myocardial hypertrophy, cardiac remodeling and cardiorenal fibrosis. The compound is also believed to have antiarrhythmic properties as it has been shown to significantly reduce ventricular arrhythmias in patients with implantable cardioverter defibrillators.
Patients suffering from heart failure with reduced ejection fraction show impaired heart rate variability, knowing that in these patients such impairment is highly associated with an increased risk of sudden cardiac death.
In its pivotal study, sacubitril/valsartan demonstrated a significant advantage over enalapril in terms of cardiovascular mortality and rehospitalization.
Against this background, this study was designed to analyze the largely unknown electrophysiological effects of sacubitril/valsartan on the autonomic cardiac nervous system by determining heart rate variability.
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
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic severe heart failure with reduced ejection fraction (LVEF ≤40%,)
- •Age > 20 years
- •Consent capacity
- •Sinus rhythm
- •Suitable for a drug conversion from AT1/ACE inhibitors to sacubitril/ valsartan
排除标准
- •Age < 18 years
- •Atrial fibrillation
- •Pregnancy
- •Lack of consent capacity
- •Contraindications for a therapy with sacubitril/ valsartan
结局指标
主要结局
Changes in serum potassium level (mmol/l)
时间窗: 24 months
Changes in laboratory parameters (glomerular filtration rate ml/min)
Changes in heart rate variability
时间窗: 24 months
Changes in heart rate variability after 3 months of treatment with sacubitril/ valsartan
Changes in left ventricular ejection fraction (%)
时间窗: 24 months
Changes in left ventricular ejection fraction (%) assessed by transthoracic echocardiogramChanges in echocardiographic parameters (left ventricular parameters)
Changes in mitral insufficiency grade
时间窗: 24 months
Changes in mitral insufficiency grade assessed by transthoracic echocardiogram
Changes in serum NT-proB-Type natriuretic peptide (ng/l)
时间窗: 24 months
Changes in laboratory parameters (serum NT-proB-Type natriuretic peptide (ng/l)
Changes in Serum creatinine level (mg/dl)
时间窗: 24 months
Changes in laboratory parameters (Serum creatinine level (mg/dl)
Changes in glomerular filtration rate (ml/min)
时间窗: 24 months
Changes in laboratory parameters (glomerular filtration rate ml/min)
次要结局
未报告次要终点