A prospective, randomized, active controlled, crossover, investigator-initiated study comparing the efficacy and safety of innovator sacubitril and valsartan along with generic sacubitril and valsartan in patients of Heart Failure with Reduced Ejection Fraction (HFrEF).
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in the GLS score of both arms
研究概览
简要总结
In this study, patients with an established diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) will be screened and enrolled if eligible (Visit 1 - Baseline). Eligible patients will be randomly assigned to one of two treatment arms in a 1:1 ratio to receive either the innovator Sacubitril/Valsartan formulation or the generic Sacubitril/Valsartan formulation. The study will follow a crossover design, where each patient will receive one formulation for the first 8 weeks and then switch to the alternate formulation for the remaining 8 weeks. The study duration will be 16 weeks, with scheduled visits at the end of Week 4 (Visit 2 - Follow-up), Week 8 (Visit 3 - Crossover), Week 12 (Visit 4 - Follow-up), and Week 16 (Visit 5 - End of Study). All enrolled patients will be instructed to take the assigned study medication twice daily (BID) for the entire duration of the 16-week study period, with continuous monitoring for efficacy and safety parameters at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender between 18-75 years of age with a confirmed diagnosis of HFrEF (left ventricular ejection fraction (LVEF) less than or equal to 45%), based on echocardiography.
- •Patients having a left ventricular Global Longitudinal Strain (GLS) Score of more than or equal to 15 measured through speckle-tracking echocardiography (STE) or 2D echocardiography.
- •Patients with HFrEF who have not previously been treated with Sacubitril/Valsartan
- •Patients who are on stable doses of beta blockers, mineralocorticoids and or SGLT2 inhibitors since last 4 weeks
- •Patients willing to be enrolled for the study and able to provide informed consent.
排除标准
- •1.Patient with known hypersensitivity to Sacubitril/Valsartan or any component of the formulation.
- •2.Patients receiving concomitant medications that interfere with Sacubitril/Valsartan.
- •3.Known patients with moderate renal impairment (eGFR less than 60 mL/min/1.73 m²) or significant liver disease (Child-Pugh B or C).
- •4.Patient with Uncontrolled hypertension (blood pressure more than 160/100 mmHg) or clinically significant arrhythmias.
- •5.Patients who have used Sacubitril/Valsartan within the last 4 weeks.
- •6.Patients who have participated in another clinical trial within the last 30 days.
- •7.Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception.
- •8.Patients unwilling or unable to comply with the study protocol and requirements.
结局指标
主要结局
Change in the GLS score of both arms
时间窗: at the end of week 8 as compared to baseline (Day 0)
次要结局
- Change in the GLS score of both arms(1. At the end of Week 12 & 16 compared to Week 8)
- Change in the GLS (A2C, A4C, ALAX) score and Average Time to Peak (TTP) value of both arms(At the end of Week 12 & 16 compared to Week 8)
- Change in the GLS (A2C, A4C, ALAX) score and Average TTP value of both arms(At the end of Week 04 & 08 compared to Baseline)
研究者
Dr Jayesh Sanmukhani
Clinexcel Research