The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction: The RSVP-AMI Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- One week major adverse cerebrovascular and cardiovascular events (MACCE)
研究概览
简要总结
Sacubitril/Valsartan (SAC/VAL) is a new treatment of congestive heart failure (CHF) recently indicated as class I, level of evidence B in the recent European Society of Cardiology (ESC) guidelines 2016 of CHF. PARADIGM-HF trial demonstrated a significant improvement of morbidity and mortality with SAC/VAL in comparison to enalapril. So far, no data available about the effect of usage of SAC/VAL post-acute myocardial infarction (AMI) except in animal experimental models.
The purpose of the research is evaluation of the effects of SAC/VAL in post-AMI in comparison to the traditional Angiotensin Converting Enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in a real-life clinical trial in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.
详细描述
Background and study rationale:
Sacubitril/Valsartan (SAC/VAL) is now approved by the U.S. Food and Drug Administration (FDA) for heart failure with reduced ejection fraction (HFrEF) and also, recently indicated as class I indication, level of evidence B in the European Society of Cardiology (ESC) guidelines 2016 on congestive heart failure (CHF).(1) PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SAC/VAL In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalization for CHF by 20% with a 16% reduction in all-cause mortality.(2) So far, no available data about the effect of usage of SAC/VAL in post-AMI except in animal experimental models that proved efficacy of SAC/VAL in preventing AMI-induced LV dysfunction compared with SAC/VAL, also significantly attenuated LV scar size following AMI compared with placebo .(3)
Aim of the work:
- This study aims to investigate the effects of SAC/VAL in post-AMI through using it instead of conventional Angiotensin Converting enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.
- Design: Randomized open label interventional clinical trial.
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
- •Post-AMI patients who underwent successful PPCI and LVEF ≤40%.
排除标准
- •Post-AMI patients who underwent successful PPCI and LVEF >40%.
- •History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
- •Symptomatic hypotension and/or an SBP < 100 mmHg.
- •Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula or serum potassium > 5.2 mmol/L.
研究组 & 干预措施
Sacubitril/Valsartan
In successfully revascularized post-AMI patients with LVEF ≤40% Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.
干预措施: Sacubitril / Valsartan Oral Tablet [Entresto] (Drug)
Valsartan
In successfully revascularized post-AMI patients with LVEF ≤40% Valsartan with an initial dose of 40 mg PO BID, with subsequent titrations to target maintenance dose of 160 mg BID as tolerated.
干预措施: Sacubitril / Valsartan Oral Tablet [Entresto] (Drug)
结局指标
主要结局
One week major adverse cerebrovascular and cardiovascular events (MACCE)
时间窗: 1 week after AMI
Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 1 week after AMI
Change in the ejection fraction during hospital stay, 3 months and 6 months after AMI.
时间窗: In hospital, 3 months and 6 months after AMI
Change in the ejection fraction assessed by transthoracic echocardiography assessment (TTE) during hospital stay, 3 months and 6 months after AMI.
Twenty four weeks major adverse cerebrovascular and cardiovascular events (MACCE)
时间窗: 24 weeks after AMI
Major adverse cerebrovascular and cardiovascular events (MACCE) will be assessed 24 weeks after AMI
次要结局
未报告次要终点
研究者
Abdallah Almaghraby
Senior Registrar of Cardiology and Angiology
The Young Investigator Group of Cardiovascular Research