Therapeutic outcomes of modulation of cardiometabolic peptides by Angiotensin Receptor-Neprilysin Inhibitor in patients of Heart Failure- A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in the serum levels of endothelin-1, neuropeptide Y, and bradykinins
研究概览
简要总结
A novel class of angiotensin receptor-neprilysin inhibitor (ARNI) has been approved as a potential therapeutic avenue in patients of heart failure with reduced ejection fraction (HFrEF). While the inhibition of neprilysin and resulting elevation of natriuretic peptides is believed to exert cardioprotective effects, elevated levels of other neprilysin substrates such as endothelin-1, bradykinin, and neuropeptide Y is expected to cause deleterious effects such as cardiac fibrosis, pulmonary hypertension, impaired glucose tolerance and angioedema. The objectives of the present study are:• **Primary:**To assess the association between change in endothelin-1 levels and cardio-metabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy
• Secondary:
• To analyse association between change in neuropeptide Y (NPY) levels and cardiometabolic outcomes* in patients of HFrEF on valsartan-sacubitrilcompared to standard care of therapy.
• To measure association between change in bradykinin levels and cardiometabolic outcomes* in patients of HFrEF on valsartan-sacubitril compared to standard care of therapy
. To assess adverse events in patients of HFrEF on valsartan-sacubitril and standard care of therapy
*To specify, cardiometabolic outcomes include 2-D echo markers such as left ventricular ejection fraction (LVEF), biochemical markers such as brain natriuretic peptide (BNP)and NT-pro BNP levels and metabolic parameters such as blood glucose and body weight
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients of 18 years of age and above and individuals of both genders diagnosed with heart failure (NYHA class II-IV) with ejection fraction less than 40 % irrespective of the etiology of heart failure and who give consent for participation in the study, shall be the study participants.
排除标准
- •Patients of heart failure with a recent history of serious cardiovascular event such as myocardial infarction, stroke, or other thromboembolic event in last one month
- •Patients of heart failure with sepsis
- •Patients of heart failure with EF ≥ 40%
- •Patients who refuse to participate.
结局指标
主要结局
Change in the serum levels of endothelin-1, neuropeptide Y, and bradykinins
时间窗: at baseline, 4 weeks, 24 weeks
次要结局
- • Improvement in 2-D Echo markers like(Left ventricle ejection fraction (LVEF), left ventricle end diastolic volume index (LVEDVI), left ventricle end systolic volume index (LVESVI), at 1-month, 6 month and 12 month compared to baseline.)
研究者
Upinder Kaur
IMS-BHU