Safety and Efficacy Comparison of 5 mg and 10 mg of Dapagliflozin in Patients with Heart Failure with Reduced Ejection Fraction
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- 1. To compare change in NTproBNP from baseline
研究概览
简要总结
this Randomized, open labeled control trial entitled “Safety and Efficacy Comparison of 5 mg and 10 mg ofDapagliflozin in Patients with Heart Failure with Reduced Ejection Fraction” will be conducted at the department of cardiology, MDM hospital attached to Dr S.N. Medical College, Jodhpur. after randomization and applying of inclusion and exclusion criteria patients will enter into this trial. initial assessment with routine investigation and NTproBNP, 2D echocardiography will be done. patient will be followed at 1month, 3month and 6month. than we will apply statistical analysis on collected data and make inference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligibility requirements included an age of more than 18 years, an ejection fraction of 40% or less, and New York Heart Association (NYHA) class II, III, or IV symptoms.
排除标准
- •unacceptable side effects with dapagliflozin in past, recent treatment with dapagliflozin, Hypotension, eGFR below 30ml/minute.
结局指标
主要结局
1. To compare change in NTproBNP from baseline
时间窗: 1. To compare change in NTproBNP from baseline at the end of 1 month, 3 month and 6 month. | 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E’) from baseline at the end of 1 month, 3 month and 6 month. | 3.Incidence of adverse events during 6 months.
2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E’) from baseline
时间窗: 1. To compare change in NTproBNP from baseline at the end of 1 month, 3 month and 6 month. | 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E’) from baseline at the end of 1 month, 3 month and 6 month. | 3.Incidence of adverse events during 6 months.
3.Incidence of adverse events
时间窗: 1. To compare change in NTproBNP from baseline at the end of 1 month, 3 month and 6 month. | 2.To compare change in Echocardiographic changes (ejection fraction, left ventricular end diastolic diameter, left ventricular diastolic dysfunction E/E’) from baseline at the end of 1 month, 3 month and 6 month. | 3.Incidence of adverse events during 6 months.
次要结局
- The secondary outcomes were the total number of hospitalizations for heart failure (including repeat admissions) & cardiovascular deaths(At the end of 6th month.)
研究者
Ala Ram
Dr. S. N. Medical college jodhpur