"Sacubitril plus Valsartan Vs Ramipril in acute myocardial infarction with heart failure with reduced and mid range ejection fraction :A Randomized control trial"
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Improvement in LVEF% (increase in LVEF by 10% from baseline) measured by Simpson’s rule
研究概览
简要总结
ARNI is a novel combination which has been recently introduced in heart failure reduced ejection fraction (HFrEF) and mid-range ejection fraction (HFmEF) treatment regimen and provides symptomatic relief, improve New York Heart Association (NYHA) functional class, reduces rate of readmission for heart failure and also reduces mortality significantly. However, the number of original researches related to ARNI vs ACEI/ARB are scarce and most of them are in pipeline. This study in our institute would enlighten about the change in ejection fraction, NYHA class, NT pro -BNP level, serum k+, creatinine level when used in patients just after myocardial infarction with heart failure with reduced ejection fraction (HFrEF) and HFmEF and follow up for a period of 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosis of spontaneous AMI based on the universal MI definition (2018) -with randomization to occur between 12 hours and 7 days after index MI presentation.
- •2.EF would calculate using ECHO after index MI presentation and prior to randomization 3.Systolic blood pressure at enrolment would be minimum ≥100mmHg irrespective of ongoing beta blocker or ACEI.
排除标准
- •1.Cardiogenic shock 2.Coronary artery bypass graft (CABG) 3.Right ventricular MI 4.A known history of angioedema 5.Stroke /transient ischemic attack 6.Bilateral renal artery stenosis 7.Obstructive cardiomyopathy 8.Serum creatinine >2.2 mg/dl 9.Total bilirubin > 3.0 mg/dL) 10.Cirrhosis 11.Previous use of ARNI 12.History of malignancy.
结局指标
主要结局
Improvement in LVEF% (increase in LVEF by 10% from baseline) measured by Simpson’s rule
时间窗: 15 months
次要结局
- Monitoring change in NYHA functional class(Monitoring NT pro BNP level in blood)