CTRI/2023/01/049280尚未招募2/3 期
A Prospective Interventional randomized study to assess efficacy of Angiotensin Receptor Nephrilysin Inhibitor (Sacubitril/Valsartan) in right ventricular systolic dysfunction with normal LV functionâ€
MDM hospitalDr SN Medical College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年1月30日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in clinical ie NYHA class and echo parameter ie TAPSE,PASP,RV S,FAC.
研究概览
简要总结
ARNI is approved for heart failure with reduced ejection fraction.so our study will be aiming to assess efficacy of ARNI in RV systolic dysfunction with normal LV function.so patients will be enrolled and randomized in 2 groups by block randomization and will be assessed at baseline ,1 month, 3 month by blood and echo parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Right Ventricular systolic dysfunction with Normal Left ventricular systolic function as diagnosed by transthoracic echocardiography parameters such as TAPSE(<16mm), PAsP(>25mm Hg), tricuspid annular velocity(<10 cm/sec), Fractional area change(<35%) and blood markers such as NT-proBNp(>400pg/ml).
排除标准
- •1.Patients with LVEF <50% 2.Pregnancy
- •Severe hepatic impairment (Child.
- •Pugh C) 4.Severe renal imapairment (eGFR<30 ml/min/1.73m2) •Hypersensitivity to any component of the product •A prior history of angioedema due to an ACEI or ARB.
结局指标
主要结局
Improvement in clinical ie NYHA class and echo parameter ie TAPSE,PASP,RV S,FAC.
时间窗: First at baseline,1 month, then at 3 month
次要结局
- CV death, Hypotension, total HF hospitalization.(CV death, Hypotension, total HF hospitalization over 3 months)
研究者
研究点 (1)
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